Requirement for the Development

of Pharmacy Facilities
in Hospitals, Health Clinics and Other Health Facilities,
Ministry of Health, Malaysia

PHARMACEUTICAL SERVICES DIVISION

MINISTRY OF HEALTH, MALAYSIA

3rd Edition 2009

First Print, 2009
Pharmaceutical Services Division
Ministry of Health, Malaysia

ALL RIGHTS RESERVED

No part of this publication may be reproduced, stored or transmitted

in any form or by any means whether electronic, mechanical,
photocopying, tape recording or others without written permission
from the Senior Director of Pharmaceutical Services, Ministry of Health,
Malaysia.

Perpustakaan Negara Malaysia Cataloguing-in-Publication Data

Requirement for the Development of Pharmacy Facilities in Hospitals,
Health Clinics and Other Health Facilities, Ministry of Health, Malaysia.

ISBN 978-983-3433-49-0
Preface

The Ministry of Health, Malaysia is continuously and

proactively looking into areas that need improvement
and expansion, in order to keep abreast with recent
developments besides meeting the demands and
expectations of the patients and stake holders. The
policies, procedures and guidelines on development
requirements are revised and improved dynamically, to
ensure quality services to the public.
Appropriate infrastructure of healthcare facilities is a must to meet today’s healthcare service
requirements. Thus, it is timely for the Pharmaceutical Services Division, Ministry of Health, and
Malaysia to publish the 3rd edition of ‘The Requirements for Development of Pharmacy Facilities in
Hospitals, Health Clinics and Other Health Facilities in Ministry of Health, Malaysia’. I am certain that
the content is up-to-date, applicable, and meets the relevant standards.

Proper planning is an essential process in both developing new facilities and upgrading existing
ones. Development in accordance with the standard requirements will ensure that the
department has a smooth workflow, besides adequate and appropriate infrastructures and
equipments. Rectification of substandard facilities will incur additional cost to the government
and hence, delay service delivery. Thus, this document should be used as a reference by those
involved in the planning, development and upgrading of pharmacy departments in hospitals and
health clinics.

Finally, I would like to convey my appreciation to the Pharmaceutical Services Division, Ministry
of Health, Malaysia and the committee members for their tireless efforts and commitment to
revise and publish the third edition of ‘The Requirements for Development of Pharmacy Facilties in
Hospitals Health Clinics and Other Health Facilities, Ministry of Health, Malaysia’.

Thank you.

Tan Sri Dato’ Seri Dr. Hj Mohd. Ismail Merican

Director General of Health
Ministry of Health, Malaysia

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l i

Foreword

In tandem with the progressive development of new

hospitals and health clinics by the Ministry of Health
throughout the country, suitable guidelines on the
development requirements are needed to assist those
involved in planning. This has prompted the
‘Requirement for Development of Pharmacy Facilities in
Hospitals, Health Clinics and Other Health Facilities,
Ministry of Health, Malaysia’ to be revised and published as the 3rd
edition. This initiative is to ensure the standardised development of
Good Hospital and Public Health Pharmacy Practice meets the current
requirements imposed by the Ministry of Health.
This guideline focuses on the requirements and specifications for developing pharmacy facilities
in new hospitals and health clinics. It also serves as a reference for upgrading existing facilities.

Compared to the earlier edition, the present requirements of space, layout, equipments and
human resource for pharmacy services are more detailed and comprehensive. Requirements for
new services such as Emergency Pharmacy and Ambulatory Care Pharmacy are also incorporated
into this new edition. The requirements of Good Preparation Practice (GPP) especially for clean
rooms have also been updated to keep abreast with current international standards as laid down
by Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international organization of
which Malaysia is a member since January 2002.

I sincerely hope that this guideline will benefit all relevant parties. I would like to take this
opportunity to congratulate and to express my appreciation to the Pharmacy Practice Working
Committee (Hospitals and Health Clinics) for their efforts in producing this important guide.

Thank you.

Eisah binti A. Rahman

Senior Director of Pharmaceutical Services
Ministry of Health, Malaysia

ii l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
Prelude

First of all, I would like to convey my gratitude to the

Pharmacy Practice Working Committee (Hospitals and
Health Clinics) for their hard work to come up with the
3rd edition of ‘Requirement for Development of
Pharmacy Facilities in Hospitals, Health Clinics and Other
Health Facilities, Ministry of Health Malaysia’. It is very
timely and appropriate for Pharmaceutical Services,
Ministry of Health to publish this guideline, as there are vast changes in
our healthcare services since the last edition in 2003.
The primary objective of this book is to assist those involved in planning, developing and
upgrading pharmacy facilities. It also aims to be of benefit to pharmacist and others who are
engaged in managing the facilities. The recommendations in this book are made by taking into
account the pharmacy service policies, the fulfillments of customers’needs, pharmacy inventories
and personnel safety, work flows and conducible working environment.

I believe that the content of this book will also serve as a standard reference for all pharmacists
in the hospital and health clinics on the design, space and layout requirements, equipment and
manpower needs. I therefore, strongly suggest to all pharmacists to look into the possibilities of
upgrading their respective facilities based on the recommendations made in this book.

Finally, I would like to congratulate and thank all parties that has contributed to the success of the
publication of this book.

Thank you.

Hasnah binti Ismail

Director
Pharmacy Practice and Development Division
Ministry of Health Malaysia

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l iii

Editorial Board

1. Cik Hazimah bt. Othman

2. Encik Sulaiman bin Ahmad
3. Encik Tan Chin Chai
4. Puan Rosidah bt. Mohd Din
5. Puan Rosnaini bt. Kamaruddin
6. Encik Abdol Malek bin Abdul Aziz
7. Puan Salbiah bt. Mohd Salleh
8. Puan Zainab bt. Md. Yusuf
9. Puan Maimunah bt. Wasli
10. Cik Kadariah bt. Mohd. Ali
11. Puan Narimah bt. Mohd. Yusof
12. Puan Che Pun bt. Bujang
13. Puan Kamarunnesa bt. Mokhtar Ahmad
14. Puan Rokiah bt. Ishak
15. Encik Mohd. Zamri bin Baharuddin
16. Puan Azizah bt. Ab. Ghani
17. Encik Zaini bin Tahir
18. Puan Nor Aida bt. Sanusi
19. Puan Ainul Salhani bt. Abdul Rahman
20. Puan Saidatul Raihan bt. Ibrahim
21. Puan Siti Fauziah bt. Narawi
22. Cik Ng Chew Beng
23. Puan Norharlina bt. Sulaiman
24. Encik Mohammad Nazeri bin Md. Dazali
25. Encik Mohd. Dziehan bin Mustapa
26. Encik Mohd. Nasrul bin Mohd. Nor
27. Puan Sarah a/p Nagalingam
28. Encik Yusni Rizal bin Khairul Anuar
29. Cik Sarah bt. Abdullah

iv l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
Table of Content

Preface i
Foreword ii
Prelude iii
Editorial Board iv
Table of Content v
Introduction 1

CHAPTER 1 Ambulatory Care Pharmacy 3

CHAPTER 2 Inpatient Pharmacy 33

CHAPTER 3 Production Pharmacy 49

CHAPTER 4 Hospital Pharmacy Procurement And Supply 77

CHAPTER 5 Health Clinic Outpatient Pharmacy 97

CHAPTER 6 District Health Pharmacy Procurement And Supply 115

Glossary 130

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l v

vi l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
Introduction

PHARMACY SERVICES IN HOSPITALS AND HEALTH CLINICS

Apart from the long-established activities of production and supply of medicines, the current
Pharmacy Department of hospitals and health clinics shall provide comprehensive
pharmaceutical care to patients with emphasis on clinical pharmacy. The quality system of the
department shall consist of the following components; an organisational structure with clearly
defined tasks, responsibilities and qualifications, a well-structured and sufficiently detailed
documentation system, personnel having sufficient knowledge of quality management and a
motivation for quality service, audit, and availability of necessary facilities and resources.
Pharmacy personnel shall work with various disciplines and departments within the hospitals or
health clinics in monitoring the quality use of medicines.

Services provided by the Pharmacy Department are categorised into three main functions with
various activities:

A. Patient Care

i) Outpatient
Dispensing, patient medication counseling and compounding extemporaneous
preparations.

ii) Inpatient
Supplying medicines to wards, units and satellite pharmacies, patient medication
counseling, ward rounds (inclusive of patients on TPN and cytotoxic drugs, and
compounding extemporaneous preparations.

iii) Clinical Pharmacokinetics

Monitoring individual patient’s medicine(s) level through laboratory analysis.

iv) Drug and Poison Information Services

Collecting and disseminating medicine and poison information to patients and
health personnel.

B. Pharmaceutical Preparation

i) Sterile preparation
Preparing intravenous admixtures, parenteral nutrition, sterile eye-drops and
reconstituting cytotoxic drugs.

ii) Galenical preparation

Preparing creams, lotions and oral solutions that are not available commercially.

iii) Repacking of medicines

Packing of commonly used tablets/capsules and galenicals into individual units to
facilitate dispensing.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 1

C. Procurement and supply

i) Purchasing
Ordering/buying medicines to be used by the hospital and health clinic.

ii) Storage
Safe keeping the medicines purchased in the store.

iii) Distribution
Supplying the medicines to various disciplines and units within the hospital
community polyclinics.

Generally, all hospitals and health clinics within the Ministry of Health run all these three main
functions but the type and extent of activities depends on the size, type and specialties of the
facilities.

2 l REQUIREMENTS FOR THE DEVELOPMENT OF PHARMACY DEPARTMENT IN HOSPITALS AND HEALTH CLINICS, MINISTRY OF HEALTH, MALAYSIA
 AMBULATORY CARE PHARMACY
1 AMBULATORY CARE PHARMACY
1.1 INTRODUCTION 5
1.2 OBJECTIVES 5
1.3 POLICIES 5
1.3.1 General Operational Policies 5
1.3.2 General Development & Maintenance Policies 6
1.3.3 Outpatient Pharmacy 8
1.3.4 Emergency Pharmacy 8
1.3.5 Day Care Pharmacy 8
1.3.6 Medication Therapy Adherence Clinic 8
1.4 MECHANICAL & ELECTRICAL REQUIREMENTS 8
1.4.1 Power Supply 8
1.4.2 Air Conditioning System 9
1.4.3 Lighting System 9
1.4.4 Alarm System 9
1.5 DESIGN, LAYOUT AND SPECIFICATION 9
1.5.1 Structural Design
a) Wall 9
b) Floor 10
c) Ceiling 10
d) Door 10
e) Window 10
1.5.2 Outpatient Pharmacy
a) Patient Waiting Area 11
b) Counters 11
c) Filling Workstation 13
d) Extemporaneous Area 13
e) Storage Area 14
f ) Patient Counselling Room 14
g) Office Area 15
h) Ancillary Area 15
1.5.3 Emergency Pharmacy
a) Patient Waiting Area 16
b) Counters 16
c) Filling Workstation 18
d) Extemporaneous Area 18
e) Storage Area 19
f ) Patient Counselling Room 19
g) Ancillary Area 19

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 3

 1.5.4 Day Care Pharmacy
a) Patient Waiting Area 20
b) Counters 20
c) Filling Workstation 22
d) Extemporaneous Area 22
e) Storage Area 23
f ) Patient Counselling Room 23
g) Ancillary Area 24
1.5.5 Medication Therapy Adherence Clinic 24
1.6 SPACE REQUIREMENT 24
1.7 EQUIPMENT REQUIREMENT 24
1.8 MANPOWER REQUIREMENT 24

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
LIST OF APPENDIX
A1.1 Space Requirement for Outpatient Pharmacy 25
A1.2 Space Requirement for Emergency/Day Care Pharmacy 26
A1.3 Space Requirement for Medication Therapy Adherence Clinic 26
B1.1 Design and Layout Plan For Outpatient Pharmacy 27
B1.2 Design and Layout Plan For Emergency/Day Care Pharmacy 28
C1 Equipment Requirement For Ambulatory Care Pharmacy 29
D1 Manpower Requirement For Ambulatory Care Pharmacy 32

4 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
1. AMBULATORY CARE PHARMACY

1.1 INTRODUCTION

Ambulatory Care Pharmacy (ACP) Services shall provide optimal pharmaceutical care
through the provision of medicines to patients in an accurate and timely manner for all
Ministry of Health, Malaysia (MOH) prescriptions. ACP shall be sited in the vicinity of clinics,
emergency & trauma and day care centres.

1.2 OBJECTIVES

1.2.1 To ensure the facility design and space area are adequate to provide medication
dispensing, including extemporaneous product/s where appropriate.

1.2.2 To ensure facility design and space area are adequate to provide medication
counselling service to patients or caretakers (inclusive of medication therapy
adherence at the appropriate clinics), thus improving treatment outcome.

1.2.3 To acquire and implement technological advances wherever possible to allow ACP
to strengthen patient-focused care.

1.2.4 To ensure proper dissemination of medicines information through acquired and

implemented technological advances to the public and other healthcare providers
thus promoting quality use of medicines.

1.3 POLICIES

1.3.1 General Operational Policies

a) Outpatient Pharmacy shall be located near the consultation / treatment

rooms.

b) Dispensing of medicines shall be based on an authentic written or on-line

prescriptions issued from the clinics / units / departments of hospitals and
health institutions within the Ministry of Health, Malaysia (MOH).

c) “Island Dispensing System” shall be adopted, whereby all prescriptions

received shall be screened by pharmacist, medications filled, labelled, counter
checked and dispensed to prevent medication error at point of dispensing.

d) All prescriptions/ order received shall be screened and verified by authorised

staff at the specified counter /station.

e) Any intervention if necessary shall be communicated to the prescriber and

rectified.

f) Screened prescriptions shall be sent to filling station for labeling and filling
process.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 5

 g) All filled prescriptions shall be counter-checked and verified by another
authorised staff.

h) Medicines shall be made available in sufficient quantity, stored in appropriate

storage condition and handled by trained and qualified personnel. The unit
store shall store not less than 4 weeks stock while counter stock not less than
2 weeks stock.

i) The expiry date of the medicines kept shall be regularly monitored by the
Pharmacy staff to avoid expiration in storage.There shall be sufficient space to
implement FEFO (First Expiry First Out).

j) Integrated Drug Dispensing System (IDDS) shall be implemented (refer

“Garispanduan Sistem Pendispensan Ubat Bersepadu, KKM”). All necessary
communication and networking equipments shall be installed.

k) All supply and use of Dangerous Drugs / Psychotropic Substances shall be

recorded in accordance to the requirements of relevant Acts and Regulations.

l) Pharmacist shall be in-charge of supplying Dangerous Drugs and Psychotropic

Substances.

m) Every health clinic Outpatient Pharmacy shall establish Drug and Poison
Information Service (DPIS), medication counseling service, Medication
Therapy Adherence Clinic (MTAC), and pharmacy education services.

n) Safety and security of the staff, equipment and medicines shall not be
compromised. Fire fighting equipment, smoke detector and automatic trigger
alarm system shall be appropriately in place.

o) The sub-store shall be locked when the outpatient pharmacy is non-

operational.

p) Access to pharmacy working area shall be restricted. Access card and

electronic safety controlled doors shall be in place and closed circuit
televisions (CCTVs) shall be installed. Emergency exit / escape door shall be
available with clear signage.

1.3.2 General Development & Maintenance Policies

a) An appropriate conducive space shall be provided for pharmacy waiting area.

b) All counters shall be of open design and comply with guidelines provided by
Pharmacy Services Division, Ministry of Health.

c) Every counter shall be provided with computer terminal or online dispensing

system.

d) Outpatient Pharmacy counter shall be of open counter design with no barrier

between patient and pharmacy staff and between one staff to another.

e) The Special Pharmacy Care (SPC) counter shall be provided to serve wheel

6 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
chair bound patients, geriatrics, handicap and mother and children. The
counter shall be of sitting position for both patient and staff.

f) A designated area shall be provided for the storage and dispensing of all filled
medicines waiting for collection, which are prepared for patients through
appointment systems (e.g. SMS & Take).

g) Complete and appropriate Queue Management System shall be made

available with sufficient quantity of digital calling system display panels
located at strategic areas.

h) Sufficient space shall be provided for storage of all dispensed prescriptions

and other documents.

i) The filling station design shall take into consideration the work flow, the
handling material, the equipment, the manpower and the workload of the
pharmacy. Adequate storage space with modular storage rack, cabinet or
cupboard shall be considered.

j) Compounding of extemporaneous preparations which are prepared to be

dispensed immediately to the patients, shall be done in specified preparation
room near to the dispensing facilities.

k) Repacking of medicines shall be carried out in a designated room properly

equipped with necessary equipments.

l) Outpatient facilities shall be complete and fully furnished with furniture,

equipment, telecommunications and networking to meet the service
requirements.

m) Proper signage shall be provided and be fixed at appropriate and strategic

locations.

n) Storage of Dangerous Drugs / Psychotropic Substances shall be in a locked

cabinet preferably with intruder alert system and in accordance to the
relevant Act and Regulation.

o) Designated room(s) for patient medication counseling shall be provided to

improve patient compliance towards medications.

p) There shall be a room for Pharmacist in-charge and modular workstations for
other pharmacists and supporting staffs.

q) Appropriate and adequate space shall be allocated for Unit Store. This Unit
Store shall be equipped with all necessary equipment and furniture to meet
GSP requirement.

r) DPIS shall be completely furnished with necessary equipment, networking,

references, telecommunications, storage systems and a discussion area. There
shall be at least a pharmacist to run the services.

s) Computerized Medicine Information shall be made available e.g.

Micromedex®, Lexicom® etc.
PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 7
 1.3.3 Outpatient pharmacy

a) Outpatient Pharmacy shall be established near the appropriate clinics to ease

the congestion of the main pharmacy.

b) For hospitals providing Drive-thru Pharmacy services, the Drive-thru

Pharmacy shall be located adjacent to the Outpatient Pharmacy.

1.3.4 Emergency Pharmacy

a) Emergency Pharmacy shall be established within the Emergency Department.

b) Emergency Pharmacy shall operate for twenty four hours per day with
Pharmacist/s and adequate support staff.

1.3.5 Day Care Pharmacy

a) Day Care Pharmacy shall be established within the Day Care Centre for new
hospitals.

b) Day Care Pharmacy shall operate during office hour with Pharmacist/s and
adequate support staff working.

1.3.6 Medication Therapy Adherence Clinic (MTAC)

a) MTAC is a clinical pharmacy service, thus it shall emphasizes on medicines

management to improve on quality, safety and cost-effectiveness of patient
care.

b) MTAC shall be operated by pharmacists who provide counselling and

education to patients with the purpose of helping to improve patient’s ability
to successfully manage their conditions and prevent debilitating symptoms.

c) MTAC shall also cover clinical pharmacokinetic consultation, laboratory

monitoring and the initiation and dosage adjustment of relevant medicines.

1.4 MECHANICAL & ELECTRICAL REQUIREMENTS

1.4.1 Power supply

a) The heating, ventilation and air-conditioning (HVAC) system is very crucial and
shall be designed to sustain the specific environment requirements under GSP.
It shall also take into consideration the indoor air quality.

b) Standby or emergency power supply shall be connected to storage rooms,

pharmaceutical refrigerators and freezer, the back door buzzer and dangerous
drugs / psycho.

c) Standby or emergency power supply shall be connected to storage rooms,

pharmaceutical refrigerators and freezer, the back door buzzer and dangerous
drugs / psychotropic substances storage alarm.

8 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
1.4.2 Air conditioning system

a) All areas shall be centrally air-conditioned.

b) The storage areas for pharmaceutical items shall be air-conditioned for 24

hours.Two sets of alternating air conditioned system shall be provided for day
and night use.

c) The patient waiting area shall be air-conditioned during operational hours.

1.4.3 Lighting system

a) Electrical outlet points shall be adequate for the optimum operation of

outpatient services.

b) Uniform lighting over the entire area is required, preferably combining

artificial and natural lighting. Localised lighting shall be provided for certain
task area such as extemporaneous compounding area. Overall good lighting
with appropriate intensity at different task level shall be considered to provide
a safe, healthy and effective work place.

c) A special lighting such as sensor spotlight, automatic emergency lighting shall

be fixed at appropriate locations such as the counters and the main entrance
of area, with lighting ranging from 300-800 lux to minimize medication error
during dispensing.

d) Ceiling lighting shall be flush mounted. Daylight white tube is preferable and
shall be of optimum average illumination.

1.4.4 Alarm system

a) Automatic triggered alarm shall be fixed at dangerous drugs / psychotropic

substances storage cabinet/area to detect any break-in.

1.5 DESIGN, LAYOUT AND SPECIFICATION

Refer Appendix B1.1 Design and Layout Plan for Outpatient Pharmacy
Refer Appendix B1.2: Design and Layout Plan for Emergency/Day Care Pharmacy

1.5.1 Structural Design

a) Wall

i) The walls shall be constructed of non-porous material and plastered both

interior and exterior.

ii) Wall finishing shall be of washable antifungal paint (indoor) and weather
proof paint (outdoor).

iii) Skirting shall be provided for office and staff areas.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 9

 iv) Walls for medicines and pharmaceutical storage (24-hrs-airconditioning)
shall be of special building material and design as to prevent
condensation.

b) Floor

i) The floor shall be non-porous, damp-proof and resistant to detergent.

ii) The floor shall be constructed from concrete and plastered smoothly,
finished with non-slippery heavy duty materials to withstand the heavy
loads, equipments and traffic.

c) Ceiling

i) The ceiling shall be made of fire-retardant, asbestos-free and non-

shedding materials or mineral fibres.

ii) The ceiling shall offer acoustic balance and control for the room or space,
preferably enhanced with sound absorption and attenuation.

d) Door

i) All doors shall be of fire-retardant material.

ii) The doors shall be two leaves, broad enough to allow free and easy
movement of supplies and handling equipment such as medication
trolleys.

iii) Doors shall be strong and reinforced to provide adequate security and
fitted with double heavy duty locks.

iv) All doors shall be protected with trolley guard.

v) Main entrance and doors to all storage areas shall be equipped with
electronic access control system.

vi) Grille/roller shutters shall be considered to be installed at issuing

counters.

vii) All exit doors shall be strategically located and fitted with luminous
emergency exit light.

e. Window

i) Windows shall be available at office and staff areas.

ii) Windows shall be either sliding or swing type.

iii) All windows shall be protected with metal grille.

10 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
1.5.2 Outpatient Pharmacy

The design and layout of the outpatient pharmacy shall take into consideration the
operational work-flow as well as personnel and material flow.

a) Patient Waiting Area

i) The area shall be spacious, with adequate lighting and properly

ventilated.

ii) Adequate space shall be provided in front of the receiving/screening

counter for patients to queue up to submit their prescriptions.

iii) Pharmacy information corner consisting of a suggestion box with writing

facilities, notice board and reading materials shall be made available.

iv) Client’s Charter, work flow and instructions to patients shall be displayed
at appropriate places.

v) The area shall be air-conditioned, equipped with chairs and television. An

electronic information display panel shall be installed.

vi) A water dispenser is an optional requirement.

b) Counters

i) General Design of Prescription Receiving, Screening, Filling, Labelling and

Dispensing Counters

• The design and layout shall take into consideration the operational
work-flow as well as personnel and material flow.

• The area shall be spacious with no barrier between pharmacy counter

staff and patient, to ensure good communication on medicines
instructions provided during the supply process.

• The area shall be air-conditioned, properly ventilated and with

adequate lighting.

• The distance from the counter to the patient’s seats (first row) shall be
at least 96” (2.4 m) to ensure comfortable sitting and facilitate
medicines collection.

• The front view portion of the counter shall be made of building

materials suitable to reflect the corporate image and professional
service of the pharmacy.

• The number of counters shall be sufficient to cater for the supply of

medicines to patients of the hospital/clinic. In a general setting where
there is a dispensing load of 100 prescriptions and lower, a minimum
of 3 counters shall be built (receiving/screening, dispensing and
special pharmacy care counter (SPC).

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 11

 • An additional counter shall be required for every additional 100
prescriptions dispensed.

• A counter for SPC shall be made available and built of sitting down
position.

• The counter shall be 2 tiered, the higher tier is of patient’s standing

height and the lower is for prescriptions receiving/screening and SPC.

• The height of the countertop shall be of patient standing height. The

height is about 42” (~1m) from the countertop floor to ensure
smoothness and ease in medicines collection.

• The width of the working counter bench shall be 24”- 26” (~0.6-
0.65m). Counter top shall be 20” (0.5m) with 10”-12” (0.25m-0.3m)
protrusion towards patient to ensure comfortable distance between
staff and patient.

• The width of the counter shall depend on size of hospital/clinic and

prescription load with minimum width of 4 feet per dispensing
counter.

• THIS or facilities adopting online prescribing shall be equipped with a

complete workstation (adequate quantity of computer, LCD monitor,
labelling printer, heavy duty printer) to receive and process order. The
counter design shall accommodate such hardware, without affecting
the width and depth of the dispensing counter.

• Computerised QMS with Voice Calling System complete with LED

display and Public Address (PA) System shall be provided. The QMS
shall be integrated with the existing computerised dispensing system
(e.g. THIS).

• Conveyor belt system shall be considered for outpatient pharmacies

with more than 4 dispensing counters. The conveyor belt system shall
be designed to meet local requirements, to ease the transfer of filled
prescription and to expedite dispensing activities.

• The counter shall be equipped with motorised roller shutter.

• Air curtain shall be provided where applicable.

ii) Receiving & Screening Counter

• The QMS ticketing and PA system equipment shall be provided at this

counter.

• The area shall cater for possible electronic transaction as well as for
general enquiries and information.

• A telephone shall be provided for prescription enquiries /

interventions

12 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
iii) Dispensing Counter

• The distance between dispensing counter staff shall be about 48”

(1.2m) to maintain comfortable working distance.

• The distance between dispensing staff sitting at the counter to

medicine filled trolley parking shall be 36 inches (0.91m) to allow easy
movement.

c) Filling Workstation

i) The area for filling prescriptions shall be located near dispensing

counters and equipped with pharmaceutical refrigerators, benches, racks
and other appropriate furniture.

ii) Adequate space shall be provided for computer hardware (including LCD
monitor, UPS, barcode reader and printers).

iii) Conveyor system shall be provided where appropriate to facilitate

transfer of filled prescriptions to the dispensing counters.

iv) The filling workstation shall be designed appropriately to house

adequate storage space for drugs and labelled in an appropriate manner
to facilitate filling process and minimize movement of the staff.

v) A workstation with glass panel and sufficient opening space shall be

provided to allow transfer of medicines to the dispensing area.

vi) The working area to conduct all operations related to medicines filling
shall be concealed from the public/patient view.

vii) The surrounding working area and workstation shall have adequate
space to ease staff, material, medicine and equipment movement to the
filling area.

d) Extemporaneous Area

i) A designated area properly equipped with necessary equipments shall

be made available for extemporaneous preparation.

ii) The area shall have a built-in concrete working bench with smooth and
acid resistant surface suitable for pharmaceutical preparation.

iii) The area shall have a stainless steel sink with an appropriate depth (at
least 16 inches deep) to avoid splashing, and 5 µm filter apparatus for hot
and cold water outlets, complete with elbow tap.

iv) The area shall have stainless steel shelves.

v) Reverse osmosis water supply system shall be made available.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 13

 e) Storage Area

i) Storage Area for Medicines (Sub-store)

• An appropriate storage room with appropriate security measures shall

be available for storing medicine.

• Suitable storage cabinets and shelves shall be made available.

• Pharmaceutical refrigerator to keep thermo labile medicines, trolleys

and suitable open racks shall be made available.

• The area shall have air-conditioning facilities working 24 hours

maintained between 18-25°C.

• Temperature of the storage area shall be monitored and documented.

• Back-up / essential power supply with trigger alarm system connected

to the main control room shall be made available for pharmaceutical
refrigerators and air conditioning facilities.

• The pharmaceutical fridge shall have temperature record system with

alarm.

• The door shall accommodate trolleys and sufficient space shall be

provided for trolley parking inside the store.

ii) Storage Of Dangerous Drugs And Psychotropic Substances

• Dangerous Drugs and Psychotropic Substances shall be stored in

lockable metal cabinets equipped with audio / visual alarm system, in
a dedicated room/pharmacist room.

iii) Storage Area for Ready-to-use Packs

• The area shall be equipped with sufficient heavy duty racks to cater for
storing internal and external preparation.

• Additional area for unloading of ready-to-use packs shall be made

available inside the store.

• The width of the door shall accommodate trolleys.

f) Patient Counselling Room

i) Dedicated room / rooms shall be located in area accessible to patients

from the waiting area and the pharmacist from inside the outpatient
pharmacy.

ii) A minimum of two counselling rooms shall be made available.The rooms

shall be half-glass panelled with blinds.

14 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
iii) Conducive counselling environment shall be made available e.g. sofa
sets, coffee table etc.

iv) The room shall be equipped with suitable racks and cupboard to store
educational materials.

g) Office Area

i) Pharmacist office shall be half-glass panelled to allow supervision.

ii) Open concept shall be applied for general office complete with
necessary equipments e.g. computers, photocopy machine, fax, and
internet access.

iii) Meeting/ discussion/ seminar room shall be equipped with appropriate

equipments e.g. LCD projectors, laptops and wireless access to the
internet.

h) Ancillary Area

i) Document room

• Sufficient space with racks shall be made available to store the entire
document as required by the laws and regulation/s

ii) Stationery Room

• Sufficient space with racks shall be made available to store the

stationery

iii) Areas for Personnel

• Personnel rest room with sufficient personnel lockers shall be

provided.

• Toilets with air locks for personnel shall be made available and shall be
located away from the activity areas and counselling room.

• Muslim male and female prayer rooms shall be provided. The qiblat of
the Muslim prayers room shall not be facing the toilet.

iv) Utility Room

• Utility room shall be provided to store cleaning materials and

equipments

v) Disposal Room

• The room shall be accessible from outside the pharmacy.

• It also functions as a temporary storage area for items meant to be

disposed e.g. boxes, plastic containers.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 15

 1.5.3 Emergency Pharmacy

a) Patient Waiting Area

i) The area shall be spacious, with adequate lighting and properly

ventilated.

ii) Adequate space shall be provided in front of the receiving/screening

counter for patients to queue up to submit their prescriptions.

iii) Pharmacy information corner consisting of a suggestion box with writing

facilities, notice board and reading materials shall be made available.

iv) Client’s Charter, work flow and instructions to patients shall be displayed
at appropriate places.

v) The area shall be air-conditioned, equipped with chairs and television. An

electronic information display panel shall be installed.

vi) A water dispenser is an optional requirement.

b) Counters

i) General Design of Prescription Receiving, Screening, Filling, Labelling and

Dispensing Counters

• The design and layout shall take into consideration the operational
work-flow as well as personnel and material flow.

• The area shall be spacious with no barrier between pharmacy counter

staff and patient, to ensure good communication on medicines
instructions provided during the supply process.

• The area shall be air-conditioned, properly ventilated and with

adequate lighting.

• The distance from the counter to the patient’s seats (first row) shall be
at least 80”(2m) to ensure comfortable sitting and facilitate medicines
collection.

• The front view portion of the counter shall be made of building

materials suitable to reflect the corporate image and professional
service of the pharmacy.

• The number of counters shall be sufficient to cater for the supply of

medicines to patients of the hospital/clinic. In a general setting where
there is a dispensing load of 100 prescriptions and lower, a minimum
of 3 counters shall be built (receiving/screening, dispensing and
special pharmacy care counter (SPC).

• An additional counter shall be required for every additional 100

prescriptions dispensed.

16 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
• A counter for SPC shall be made available and built of sitting down
position.

• The counter shall be 2 tiered, the higher tier is of patient’s standing

height and the lower is for prescriptions receiving/screening and SPC.

• The height of the countertop shall be of patient standing height. The

height shall be 42” (~1m) from the floor to ensure smoothness and
ease in medicines collection.

• The width of the working counter bench shall be 24”- 26” (~0.6-
0.65m). Counter top shall be 20” (0.5m) with 10”-12” (0.25m-0.3m)
protrusion towards patient to ensure comfortable distance between
staff and patient.

• The width of the counter shall depend on size of hospital/clinic and

prescription load with minimum width of 4 feet per dispensing
counter.

• THIS or facilities adopting online prescribing shall be equipped with a

complete workstation (adequate quantity of computer, LCD monitor,
labelling printer, heavy duty printer) to receive and process order. The
counter design shall accommodate such hardware, without affecting
the width and depth of the dispensing counter.

• Computerised QMS with Voice Calling System complete with LED

display and Public Address (PA) System shall be provided. The QMS
shall be integrated with the existing computerised dispensing system
(e.g. THIS).

• Conveyor belt system shall be considered for emergency pharmacies

with more than 4 dispensing counters. The conveyor belt system shall
be designed to meet local requirements, to ease the transfer of filled
prescription and to expedite dispensing activities.

• The counter shall be equipped with motorised roller shutter.

• Air curtain shall be provided where applicable.

ii) Receiving & Screening Counter

• The QMS ticketing and PA system equipment shall be provided at this

counter.

• The area shall cater for possible electronic transaction as well as for
general enquiries and information.

• A telephone shall be provided for prescription enquiries /

interventions.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 17

 iii) Dispensing Counter

• The distance between dispensing counter staff shall be about 48”

(1.2m) to maintain comfortable working distance.

• The distance between dispensing staff sitting at the counter to

medicine filled trolley parking shall be 36” (0.91m) to allow easy
movement.

c) Filling Workstation

i) The area for filling prescriptions shall be located near dispensing

counters and equipped with pharmaceutical refrigerators, benches, racks
and other appropriate furniture.

ii) Adequate space shall be provided for computer hardware (including LCD
monitor, UPS, barcode reader and printers).

iii) The filling workstation shall be designed appropriately to house

adequate storage space for drugs and labelled in an appropriate manner
to facilitate filling process and minimize movement of the staff.

iv) A workstation with glass panel and sufficient opening space shall be
provided to allow transfer of medicines to the dispensing area.

v) The working area to conduct all operations related to medicines filling

shall be concealed from the public/patient view.

vi) The surrounding working area and workstation shall have adequate
space to ease staff, material, medicine and equipment movement to the
filling area.

d) Extemporaneous Area

i) A designated area properly equipped with necessary equipments shall

be made available for extemporaneous preparation.

ii) The area shall have a built-in concrete working bench with smooth and
acid resistant surface suitable for pharmaceutical preparation.

iii) The area shall have a stainless steel sink with an appropriate depth (at
least 16 inches deep) to avoid splashing, and 5µm filter apparatus for hot
and cold water outlets, complete with elbow tap.

iv) The area shall have stainless steel shelves.

v) Reverse osmosis water supply system shall be made available.

18 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
e) Storage Area

i) Storage Area for Medicines (Sub-store)

• An appropriate storage room with appropriate security measures shall

be available for storing medicine.

• Suitable storage cabinets and shelves shall be made available.

• Pharmaceutical refrigerator to keep thermo labile medicines, trolleys

and suitable open racks shall be made available.

• The area shall have air-conditioning facilities working 24 hours

maintained between 18-25°C.

• Temperature of the storage area shall be monitored and documented.

• Back-up / essential power supply with trigger alarm system connected

to the main control room shall be made available for pharmaceutical
refrigerators and air conditioning facilities.

• The pharmaceutical fridge shall have temperature record system with

alarm.

• The door shall accommodate trolleys and sufficient space shall be

provided for trolley parking inside the store.

ii) Storage of Dangerous Drugs and Psychotropic Substances

• Dangerous Drugs and Psychotropic Substances shall be stored in

lockable metal cabinets equipped with audio / visual alarm system, in
a dedicated room/pharmacist room.

f) Patient Counselling Room

i) Dedicated room / rooms shall be located in area accessible to patients

from the waiting area and the pharmacist from inside the outpatient
pharmacy.

ii) A counselling room shall be made available. The room shall be half-glass
panelled with blinds.

iii) Conducive counselling environment shall be made available e.g. sofa

sets, coffee table etc.

iv) The room shall be equipped with suitable racks and cupboard to store
educational materials.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 19

 g) Ancillary Area

i) Areas for Personnel

• Personnel rest room with sufficient personnel lockers shall be

provided.

• Toilets with air locks for personnel shall be made available and shall be
located away from the activity areas and counselling room.

• Muslim male and female prayer rooms shall be provided. The qiblat of
the Muslim prayers room shall not be facing the toilet.

1.5.4 Day Care Pharmacy

Refer Appendix B1.2: Design and Layout Plan for Emergency/Day Care Pharmacy

a) Patient Waiting Area

i) The area shall be spacious, with adequate lighting and properly

ventilated.

ii) Adequate space shall be provided in front of the receiving/screening

counter for patients to queue up to submit their prescriptions.

iii) Pharmacy information corner consisting of a suggestion box with writing

facilities, notice board and reading materials shall be made available.

iv) Client’s Charter, work flow and instructions to patients shall be displayed
at appropriate places.

v) The area shall be air-conditioned, equipped with chairs and television. An

electronic information display panel shall be installed.

vi) A water dispenser is an optional requirement.

b) Counters

i) General Design of Prescription Receiving, Screening, Filling, Labelling and

Dispensing Counters

• The design and layout shall take into consideration the operational
work-flow as well as personnel and material flow.

• The area shall be spacious with no barrier between pharmacy counter

staff and patient, to ensure good communication on medicines
instructions provided during the supply process.

• The area shall be air-conditioned, properly ventilated and with

adequate lighting.

20 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
• The distance from the counter to the patient’s seats (first row) shall be
at least 80”(2m) to ensure comfortable sitting and facilitate medicines
collection.

• The front view portion of the counter shall be made of building

materials suitable to reflect the corporate image and professional
service of the pharmacy.

• The number of counters shall be sufficient to cater for the supply of

medicines to patients of the hospital/clinic. In a general setting where
there is a dispensing load of 100 prescriptions and lower, a minimum
of 3 counters shall be built (receiving/screening, dispensing and
special pharmacy care counter (SPC).

• An additional counter shall be required for every additional 100

prescriptions dispensed.

• A counter for SPC shall be made available and built of sitting down
position.

• The counter shall be 2 tiered, the higher tier is of patient’s standing

height and the lower is for prescriptions receiving/screening and SPC.

• The height of the countertop shall be of patient standing height. The

height shall be 42” (~1m) from the floor to ensure smoothness and
ease in medicines collection.

• The width of the working counter bench shall be 24”- 26” (~0.6-
0.65m). Counter top shall be 20” (0.5m) with 10”-12” (0.25m-0.3m)
protrusion towards patient to ensure comfortable distance between
staff and patient.

• The width of the counter shall depend on size of hospital/clinic and

prescription load with minimum width of 4 feet per dispensing
counter.

• THIS or facilities adopting online prescribing shall be equipped with a

complete workstation (adequate quantity of computer, LCD monitor,
labelling printer, heavy duty printer) to receive and process order. The
counter design shall accommodate such hardware, without affecting
the width and depth of the dispensing counter.

• Computerised QMS with Voice Calling System complete with LED

display and Public Address (PA) System shall be provided. The QMS
shall be integrated with the existing computerised dispensing system
(e.g. THIS).

• The counter shall be equipped with motorised roller shutter.

• Air curtain shall be provided where applicable.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 21

 ii) Receiving & Screening Counter

• The QMS ticketing and PA system equipment shall be provided at this

counter.

• The area shall cater for possible electronic transaction as well as for
general enquiries and information.

• A telephone shall be provided for prescription enquiries /

interventions.

iii) Dispensing Counter

• The distance between dispensing counter staff shall be about 48”

(1.2m) to maintain comfortable working distance.

• The distance between dispensing staff sitting at the counter to

medicine filled tray parking shall be 36 “ inches (0.91m) to allow easy
movement.

c) Filling Workstation

i) The area for filling prescriptions shall be located near dispensing

counters and equipped with pharmaceutical refrigerators, benches, racks
and other appropriate furniture.

ii) Adequate space shall be provided for computer hardware (including LCD
monitor, UPS, barcode reader and printers).

iii) The filling workstation shall be designed appropriately to house

adequate storage space for drugs and labelled in an appropriate manner
to facilitate filling process and minimize movement of the staff.

iv) A workstation with glass panel and sufficient opening space shall be
provided to allow transfer of medicines to the dispensing area.

v) The working area to conduct all operations related to medicines filling

shall be concealed from the public/patient view.

vi) The surrounding working area and workstation shall have adequate
space to ease staff, material, medicine and equipment movement to the
filling area.

d) Extemporaneous Area

i) A designated area properly equipped with necessary equipments shall

be made available for extemporaneous preparation.

ii) The area shall have a built-in concrete working bench with smooth and
acid resistant surface suitable for pharmaceutical preparation.

iii) The area shall have a stainless steel sink with an appropriate depth (at

22 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
least 16 inches deep) to avoid splashing, and 5 µm filter apparatus for hot
and cold water outlets, complete with elbow tap.

iv) The area shall have stainless steel shelves.

v) Reverse osmosis water supply system shall be made available.

e) Storage Area

i) Storage Area for Medicines (Sub-store)

• An appropriate storage room with appropriate security measures shall

be available for storing medicine.

• Suitable storage cabinets and shelves shall be made available.

• Pharmaceutical refrigerator to keep thermo labile medicines, trolleys

and suitable open racks shall be made available.

• The area shall have air-conditioning facilities working 24 hours

maintained between 18-25°C.

• Temperature of the storage area shall be monitored and documented.

• Back-up / essential power supply with trigger alarm system connected

to the main control room shall be made available for pharmaceutical
refrigerators and air conditioning facilities.

• The pharmaceutical fridge shall have temperature record system with

alarm.

• The door shall accommodate trolleys and sufficient space shall be

provided for trolley parking inside the store.

ii) Storage Of Dangerous Drugs And Psychotropic Substances

Dangerous Drugs and Psychotropic Substances shall be stored in

lockable metal cabinets equipped with audio / visual alarm system, in a
dedicated room/pharmacist room.

f) Patient Counselling Room

i) Dedicated room / rooms shall be located in area accessible to patients

from the waiting area and the pharmacist from inside the outpatient
pharmacy.

ii) A counselling room shall be made available. The room shall be half-glass
panelled with blinds.

iii) Conducive counselling environment shall be made available e.g. sofa

sets, coffee table etc.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 23

 iv) The room shall be equipped with suitable racks and cupboard to store
educational materials.

g) Ancillary Area

i) Personnel rest room with sufficient personnel lockers shall be provided.

1.5.5 Medication Therapy Adherence Clinic (MTAC) Room

a) An MTAC room shall have the same set up and requirement as Patient
Counselling Room.

b) Dedicated room / rooms shall be located in area accessible to patients from

the waiting area at the appropriate clinics.

c) Conducive counselling environment shall be made available.

d) The room shall be equipped with suitable racks and cupboard to store
educational materials.

e) Computerized Medicine Information shall be made available e.g.

Micromedex®, Lexicom® etc.

f) Certain medicines shall be kept in filing cabinet to be dispensed to patients

after consultation.

g) Adequate monitoring equipment / material shall be made available to the

patient.

1.6 SPACE REQUIREMENT

Refer Appendix A1.1 Space Requirement for Outpatient Pharmacy

Refer Appendix A1.2 Space Requirement for Emergency / Day Care Pharmacy
Refer Appendix A1.3 Space Requirement for MTAC

1.7 EQUIPMENT REQUIREMENT

Refer Appendix C1: Equipment Requirement for Outpatient / Emergency / Day Care
Pharmacy

1.8 MANPOWER REQUIREMENT

Refer Appendix D1: Manpower Requirement for Ambulatory Care Pharmacy

24 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 APPENDIX A1.1 : SPACE REQUIREMENT FOR OUTPATIENT PHARMACY

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Outpatient Pharmacy Area (square meter)
Hospital Waiting
Size Counter Drug Controlled Tabs/Caps/ Individual Pharmacist Office Record Staff Toilet Disposal Utility Prayer Area
(No. of and Store Item/ Repacking Counseling Room Space Room Rest Room Room Room for
Prescrip- Pharmacy DD Room Room and Room (Head of (Cubicles) Room Patients
tions) Work Area Internal/Ex- Unit)
ternal Liquid
Extempora-
neous/Repac-
king Room
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
<250 46 (4 38 16 3 x 14 1 X 14 12 38 10 20 2 X 10 10 10 2 X 14 46 (50
counters) (1 U44) (2 U41 & chairs)
1 U32)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
251- 500 92 (6 56 20 3 x 14 2 X 14 12 56 10 24 2 X 10 10 10 2 X 14 92 (80
counters) (1 U44) (4 U41, chairs)
1 U36)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
501-700 138 (8 75 25 3 x 14 2 X 14 14 74 14 28 2 X 10 10 10 2 X 14 138 (120
counters) (1 U48) (6 U41, chairs)
1 U36)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
701-1000 186 (10 92 32 3 x 14 2 X 45 14 100 20 30 4 X 10 10 10 2 X 14 185 (160
counters) (1 U48) (8 U41, chairs)
1 U36 &
1 U32)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
>1000 232 (12 138 36 3 x 14 3 X 45 14 120 24 32 4 X 10 10 10 2 X 16 232 (200
counters) (1 U48) (10 U41, chairs)
1 U36 &

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA

1 U32)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
The above space requirement does not include passage way

l 25
AMBULATORY CARE PHARMACY
 APPENDIX A1.2 : SPACE REQUIREMENT FOR EMERGENCY / DAY CARE PHARMACY

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
No. of Pharmacy Area (square meter)
Prescriptions /day
received from Counter and Drug Waiting Counseling
Emergency Dept/ Pharmacy Storage Area for Room
Day Care Unit Work Area Area Patients
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
<50 16 - 16 14
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
51- 100 25 16 25 14
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
101-200 36 22 30 14
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
>200 40 42 42 14
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

The above space requirement does not include passage way

APPENDIX A1.3 : SPACE REQUIREMENT FOR MEDICATION THERAPY ADHERENCE CLINIC (MTAC)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
No of MTAC according
to appropriate clinics** MTAC Room (square meter)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
1 1 X 14
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
3 2 X 14
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
6 3 X 14
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
>10 4 X 14
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

**Example : Diabetes,Cardiovascular, Warfarin, Osteoporosis, HAART, Asthma, Neurology and etc.

26 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 APPENDIX B1.1 : DESIGN AND LAYOUT PLAN FOR OUTPATIENT PHARMACY

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA

l 27
AMBULATORY CARE PHARMACY
APPENDIX B1.2 : DESIGN AND LAYOUT PLAN FOR EMERGENCY/DAY CARE PHARMACY

28 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
APPENDIX C1 : EQUIPMENT REQUIREMENT FOR AMBULATORY CARE PHARMACY

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Location

No. Equipment OP EP/DCP MTAC

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
1 Air-Condition 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
2 Audio video set/ DVD/ Television set
(For seminar room) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
3 Bar Code Labeler 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
4 Bar Code Reader 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
5 Benches 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
6 Bins (Stackable, various sizes) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
7 Book Shelf 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
8 Cabinet, Filing 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
9 Cabinet, Stainless Steel 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
10 Cabinet, Dangerous Drugs 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
11 Calculator 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
12 Chair - counter with back rest
(Adjustable for Dispensing) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
13 Chair (Office) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
14 Chair (Visitor) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
15 Chair (Waiting area) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
16 Clock 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
17 Close Circuit TV 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
18 Coffee table 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
19 Compactors 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
20 Computer sets (LCD Screen, UPS, Printer) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
21 Computer, notebook 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
22 Computerized Queue Management system
with Electronic Calling System 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
23 Digital Calling System 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
24 Dining Set for 6 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
25 Electronic door with card access 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
26 Electronic Information Display 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 29

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Location

No. Equipment OP EP/DCP MTAC

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
27 Facsimile machine 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
28 Fire Safety equipments (fire extinguishers,
fire blanket e.t.c.) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
29 Freezer 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
30 Water Filter with Hot and Cold Water Dispenser
(staff rest) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
31 Labeler (Hand) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
32 Labeler Machine 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
33 Ladder Aluminum 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
34 Measuring cylinder 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
35 Measuring jar 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
36 Microphone (PA system) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
37 Microwave (staff rest room) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
38 Mill care Storage Cabinet 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
39 Mirror 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
40 Mortar & Pestle 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
41 Notice Board 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
42 Personal protective equipment (gloves, ear
protectors and masks) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
43 Photostat machine 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
44 Pocket PC 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
45 Portable dust extractor unit 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
46 Printer LaserJet A4 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
47 Rack - heavy duty 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
48 Refrigerator Pharmaceutical, Single door 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
49 Refrigerator Pharmaceutical, Single door
(separate fridge for cytotoxic medicines) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
50 Refrigerator, Domestic 225 L (staff rest) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
51 Refrigerator, Pharmaceutical 2 door (Glass) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
52 Scale , weighing (300g) - Electronic 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
53 Sealer machine 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

30 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 AMBULATORY CARE PHARMACY
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Location

No. Equipment OP EP/DCP MTAC

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
54 Shoe rack ( For personnel room) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
55 Sofa sets (For Personnel/ counseling rooms) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
56 Spatula 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
57 Staff locker 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
58 Suggestion box with writing facilities 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
59 Table for conference room 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
60 Table/Office Chair 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
61 Tables for 6 (personnel rest room) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
62 Television set (for waiting area) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
63 Toaster 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
64 Trolley (Hand) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
65 Trolley, 2-tier stainless steel 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
66 Trolley, Instruments with guard rail 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
67 Trolley, Medicines (Emergency) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
68 Trolley, Multipurpose platform (heavy duty) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
69 Truck, Pallet (heavy-duty), Store 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
70 Vacuum Cleaner 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
71 Water Dispenser 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
72 White Board (Magnetic) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
73 Magazine rack 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
74 Blood Pressure Set 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
75 Weighing Scale With Height 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
76 INR Machine 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
77 Spirometry Machine 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
78 Glucometer Machine 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
79 Palm Top 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
80 Mobile Phone with Prepaid Card 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Legends:
OP : Outpatient Pharmacy
EP : Emergency Pharmacy
DCP : Day Care Pharmacy
MTAC : Medication Therapy Adherence Clinic
PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 31
 APPENDIX D1 : MANPOWER REQUIREMENT FOR AMBULATORY CARE PHARMACY

32 l
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
No. of prescriptions per day
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
<250 250 - 500 501-1000 >1000
Category of ––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Manpower Number of Staff Required
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
OP M OP M OP M OP M
EP/ T EP/ T EP/ T EP/ T
DCP A DCP A DCP A DCP A
Scr Ctr Co C Scr Ctr Co C Scr Ctr Co C Scr Ctr Co C
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist (U48) - - - - - - - - - - - 1 - - 1 - 1 - - 2
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist (U44) - 1 - - - - 2 - - 1 - 2 - 1 1 - 3 - 1 2
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist (U41) 1 3 1 1 1 2 7 2 2 2 3 13 2 3 3 3 15 3 5 5
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacy Assistant (U36) - - - - - - 1 - - - - 1 - - - - 1 - - -
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacy Assistant (U32) - 1 - 1 - - 1 - 1 - - 3 - 1 - - 4 - 1 -
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacy Assistant (U29) - 4 - 3 - - 7 - 3 - - 13 - 3 - - 15 - 3 -
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
General Workers - 1 - 0 - - 2 - 1 - - 3 - 1 - - 4 - 1 -
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
U41 norm 1:100

Legends
OP : Outpatient Pharmacy Scr : Screening of Prescriptions
Ctr : Dispensing Counter Co : Medication Counseling Services
EP/DCP : Emergency Pharmacy/Day Care Pharmacy MTAC : Medication Therapy Adherence Clinic
2 INPATIENT PHARMACY
2.1 INTRODUCTION 34

INPATIENT PHARMACY
2.2 OBJECTIVES 34
2.3 POLICIES
2.3.1 General Operational Policies 34
2.3.2 General Development & Maintenance Policies 35
2.4 MECHANICAL AND ELECTRICAL REQUIREMENT 36
2.5 DESIGN, LAYOUT AND SPECIFICATION 37
2.5.1 Structural Design
a) Wall 37
b) Floor 37
c) Ceiling 37
d) Door 38
e) Window 38
2.5.2 Ward Supply Pharmacy
a) Trolley Parking Bay and Waiting Area 38
b) Issuing Area 38
c) Filling Area 39
d) Extemporaneous Area 39
e) Storage Area for Medicines 39
f ) Storage Area for Bulk Items (Intravenous Solutions) 40
g) Dangerous Drug / Psychotropic Substances Room 40
h) Drug and Poison Information Services Area 40
i) Clinical Pharmacokinetic Services (TDM) Area 40
j) Management and Administrative Area 41
k) Areas for Personnel 41
l) Cleaner’s / Utility Room 41
m) Disposal Room 41
2.5.3 Satellite Pharmacy 41
2.6 SPACE REQUIREMENT 42
2.7 EQUIPMENT REQUIREMENT 42
2.8 MANPOWER REQUIREMENT 42

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
LIST OF APPENDIX
A2 Space Requirement for Ward Supply Pharmacy and Satellite Pharmacy 43
B2.1 Example of Design and Layout Plan For Ward Supply Pharmacy 44
B2.2 Example of Design and Layout Plan For Satellite Pharmacy 45
C2 Equipment Requirement For Inpatient Pharmacy 46
D2 Manpower Requirement For Inpatient Pharmacy 48

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 33

2. INPATIENT PHARMACY

2.1 INTRODUCTION

The Inpatient Pharmacy provides comprehensive pharmaceutical services to all categories

of patients from newborn to geriatric admitted to the wards of the hospital.

These include stocking and dispensing of medication, medication history investigation,

evaluation of medication and dosing on an individual patients basis, collaborating with the
doctors and nurses on the appropriate plan of care regarding drug use, discharge planning,
implementing and evaluating cost containment, drug therapy evaluation for the Drug and
Therapeutic Committee, educating and disseminating drug information to patients, family
members and other healthcare professionals.

The medication supply service is provided through Unit Dose Drug Distribution system,
which can be developed to an automated dispensing system for provision of routine
medication in unit dose packaging. This includes those which need sterile preparation in
the Production Pharmacy namely intravenous admixtures, parenteral nutrition
preparations and cytotoxic drug reconstitution. Scheduled checks shall be carried out on
medication storage and expiration, as well as in ensuring right administration of right
medications to the right patients.

2.2 OBJECTIVES

2.2.1 To ensure the Ward Supply / Satellite Pharmacy Unit design, build and maintenance
accommodate the workflows and operational requirement towards effective and
efficient medication supply to inpatients.

2.2.2 To ensure the facilities are sufficiently equipped with appropriate and adequate
resources in order to enhance the delivery of total pharmaceutical care that meets
the patients needs.

2.2.3 To acquire and implement technological advances wherever possible to allow the
inpatient pharmacy to improve patient medication supply and strengthen patient-
focused pharmaceutical care.

2.3 POLICIES

2.3.1 General Operational Policies

a) Ward Supply Pharmacy stores and provides central medication supply to all
wards/ units in the hospital including the Satellite Pharmacies.

b) The Inpatient Satellite Pharmacy shall be established to provide;

i) improved control over individual patient medication supply
ii) improved accessibility to medications and drug information,
iii) improved communication between pharmacist and other health care
team.

c) Ward Supply Pharmacy and Satellite Pharmacy shall be opened during office
hours on weekdays. Operational hours on other days and after office hours
shall be determined by departmental policies.

d) Pharmacists shall be on duty throughout the operational hours of the

inpatient pharmacy facilities.
34 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 e) All areas of drug storage shall be locked after normal working hours. Keys shall
be put under the control of pharmacist in charge.

f) Dangerous Drugs and Psychotropic Substances shall be stored under lock and
key in accordance with the requirement of relevant Acts and Regulations.

g) All written orders shall be screened and verified by pharmacists prior to filling
and dispensing.

h) Unit Dose System shall be implemented in all wards whereby patients’

medications are prepared on daily dose basis and put in individual cassettes

INPATIENT PHARMACY
of medication trolleys. All medication trolleys shall be locked and kept within
the satellite pharmacy area prior to collection by authorised ward/unit staff.

i) Sufficient After Office Hours (AOH) stock of frequently used medication, other
than Dangerous Drugs / Psychotropic Substances, shall be made available in
the wards. These medications can only be used when the inpatient pharmacy
supply is non-operational.

j) Topping up of AOH and emergency trolley medication shall be done by the

pharmacy staff.

k) Discharge medications shall be prepared and dispensed at the bedside, and

counseling shall be provided to enhance patients’ understanding and
compliance.

l) Clinical Pharmacokinetic Service shall be made available and results shall be

interpreted by the Pharmacist. In toxic cases, results shall be communicated to
the requesting doctors for immediate management.

m) Drug and Poison Information Service shall be made available and managed by
the pharmacist.

2.3.2 General Development & Maintenance Policies

a) The Ward Supply Pharmacy shall be centrally located in areas which are easily
accessible to facilitate medication supplies from the main Pharmacy Store and
to the requesting satellite pharmacies, wards and other units.

b) The Satellite Pharmacy shall be located in an area which is easily accessible to

facilitate medication supplies from the Ward Supply Pharmacy and to the
requesting wards and other units.

c) The Ward Supply Pharmacy and Satellite Pharmacy shall be located away from
public areas.

d) The Ward Supply Pharmacy and Satellite Pharmacy shall be accessible only to
the authorised pharmacy staff via ID access card.

e) Security alarm and CCTV shall be installed and operational in all access points
and drug storage areas and connected to hospital security control room.

f) The hospital shall take measures to provide adequate security both to

inpatient pharmacy staff as well as the medication stock, during and after
office hours.

g) Panic alarm shall be provided with full instruction on how to operate them
made known to the inpatient pharmacy staff.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 35

 h) Fire safety equipment shall be installed and meet the requirement of the Fire
and Rescue Department, Malaysia.

i) The storage area shall be sufficient for keeping all inventories at appropriate
stock holding levels and shall be stored in accordance to Good Storage
Practice Guidelines (GSP) and other government/ authority regulations.

j) There shall be sufficient physically separated areas with appropriate storage

conditions for orderly segregation of products namely biological, refrigerated,
inflammable and corrosive liquid and solids, cytotoxic drugs, Dangerous Drugs
and Psychotropic Substances.

k) Where controlled storage environment is required, its conditions shall be

continuously monitored using appropriate equipment at predetermined
intervals. Maximum and minimum temperature of the day shall be monitored
and recorded.

l) Expensive and attractive items shall be stored in a dedicated storage area with
limited access. All storage areas shall be properly labeled.

m) Storage of Dangerous Drugs / Psychotropic Substances in the wards / units

shall be kept under lock and key and put under the control of authorised
personnel.

n) Compounding of extemporaneous preparations which are prepared to be

dispensed immediately to the patients, shall be done in specified preparation
areas in the Ward Supply Pharmacy / Satellite Pharmacy.

o) Computerisation and online drug management system shall be made

available. Computerised identification system such as bar coding shall be
considered to be used for inventory and asset management.

p) The following requirement shall be considered to provide functional

environment for Inpatient Pharmacies:
i) Practical and suitable workstations to the work function and condition.
ii) Space for IT networking & hardware.
iii) Adequate space for housing all equipment, furniture and office
automations.
iv) Adequate issuing area.
v) Adequate storage for records and filing
vi) Pantry, rest and prayer rooms for staff
vii) An appropriate space for condemn inventory
viii) An appropriate space for disposal
ix) Storage for utilities

2.4 MECHANICAL & ELECTRICAL REQUIREMENT

2.4.1 The heating, ventilation and air-conditioning (HVAC) system shall be designed to
sustain the specific environment requirement under GSP. It shall also take into
consideration the indoor air quality.

2.4.2 All areas of Inpatient Pharmacy shall be centrally air-conditioned. Areas which
provide storage for pharmaceutical items shall have 24 hours air-conditioning
facilities.

2.4.3 Electrical outlet points shall be adequate for the optimum operation of inpatient
services.

36 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 2.4.4 Standby or emergency power supply shall be connected to storage rooms,
pharmaceutical refrigerators and freezer, the back door buzzer and Dangerous
Drugs / Psychotropic Substances storage alarm.

2.4.5 Automatic triggered alarm shall be fixed at Dangerous Drugs / Psychotropic

Substances storage cabinet/area to detect any break-in.

2.4.6 Uniform lighting over the entire Inpatient Pharmacy area is required, preferably
combining artificial and natural lighting. Localised lighting shall be provided for
certain task area such as extemporaneous compounding area. Overall good
lighting with appropriate intensity at different task level shall be considered to

INPATIENT PHARMACY
provide a safe, healthy and effective work place.

2.4.7 A special lighting such as sensor spotlight, automatic emergency lighting shall be
fixed at appropriate locations such as the medication trolley parking bay and the
main entrance of the ward supply area, with lighting ranging from 300-800 lux to
minimize medication error during dispensing.

2.4.8 Ceiling lighting shall be flush mounted. Daylight white tube is preferable and shall
be of optimum average illumination.

2.5 DESIGN, LAYOUT AND SPECIFICATION

The general design and construction shall take into consideration the functionality of
inpatient pharmacy services. The location and size shall accommodate anticipated
personnel and inventory movement, work processes and activities.

Refer Appendix B2.1 Example Of Design And Layout Plan For Ward Supply Pharmacy
and Appendix B2.2 Example Of Design And Layout Plan For Satellite Pharmacy.

2.5.1 Structural Design

a) Wall

i) The walls shall be constructed of non-porous material and plastered both

interior and exterior.

ii) Wall finishing shall be of washable antifungal paint (indoor) and weather
proof paint (outdoor).

iii) Skirting shall be provided for office and staff areas.

iv) Walls for medicines and pharmaceutical storage (24-hrs-airconditioning)

require special building material and design as to prevent condensation.

b) Floor

i) The floor shall be non-porous, damp-proof and resistant to detergent.

ii) The floor shall be constructed from concrete and plastered smoothly,
finished with non-slippery heavy duty materials to withstand the heavy
loads and traffic.

c) Ceiling

i) The ceiling shall be made of fire-retardant, asbestos-free and non-

shedding materials or mineral fibres.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 37

 ii) The ceiling shall offer acoustic balance and control for the room or space,
preferably enhanced with sound absorption and attenuation.

d) Door

i) All doors shall be of fire-retardant material.

ii) The doors shall be two leaves, broad enough to allow free and easy
movement of supplies and handling equipment such as medication
trolleys.

iii) Doors shall be strong and reinforced to provide adequate security and
fitted with double heavy duty locks.

iv) All doors shall be protected with trolley guard.

v) Main entrance and doors to all storage areas shall be equipped with
electronic access control system.

vi) Grille/roller shutters shall be considered to be installed at issuing

counters.

vii) All exit doors shall be strategically located and fitted with luminous
emergency exit light.

e) Window

i) The windows shall be available in the office and staff areas.

ii) Window shall be either sliding or swing type.

iii) All windows shall be protected with metal grille.

2.5.2 Ward Supply Pharmacy

a) Trolley Parking Bay and Waiting Area

i) Trolley parking bay shall be located in front or adjacent to the ward

supply counter. The space shall be adequate for trolley parking and
movement and shall be based on the number of wards and units served.

ii) Sufficient space and chairs for waiting area shall be provided.

b) Issuing Area

i) The area shall be easily accessible to wards and units.

ii) An open counter for supply and receiving shall be provided. The counter
shall accommodate at least two persons at the same time.

iii) Adequate storage cabinets or shelves or pigeon holes shall be made

available for holding issued items prior to ward/unit collection.

iv) Adequate space shall be provided for computer hardware (including LCD
monitor, UPS, barcode reader and printers).

38 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
c.) Filling area

i) Filling area shall be located behind the ward supply receiving counters
and shall be equipped with benches, racks, stackable bins and other
furniture.

ii) Working space shall be provided according to the workload, number of

personnel and medication trolleys involved at any one time. A minimum
of 25 square feet (7 sqm) space shall be provided for each medication
trolley attended by one personnel.

INPATIENT PHARMACY
iii) The location and design of workbench and filling station shall
accommodate personnel, material and equipment flow and facilitate
movement.

iv) Adequate space shall be provided for computer hardware (including LCD
monitor, UPS, barcode reader and printers).

v) Adequate lighting of 500 - 800 lux shall be made available to prevent

errors in filling.

d) Extemporaneous Room

i) A designated area properly equipped with necessary equipments shall

be made available for extemporaneous preparation.

ii) The area shall have a built-in concrete working bench with smooth and
acid resistant surface suitable for pharmaceutical preparation.

iii) The area shall have a stainless steel sink with an appropriate depth (at
least 16 inches deep) to avoid splashing, and 5 µm filter apparatus for hot
and cold water outlets, complete with elbow tap.

iv) The area shall have stainless steel shelves.

v) Reverse osmosis water supply system shall be made available.

e) Storage Area for Medicines

i) Appropriate storage rooms / areas with appropriate security measures

shall be available for storing medicine.

ii) The door and space between racks shall accommodate trolleys and
sufficient space shall be provided for trolley parking inside the store.

iii) There shall be enough space to accommodate portable or built-in

storage cabinets / shelves, suitable open racks and pharmaceutical
refrigerators to keep thermo labile medicines.

iv) Designated areas for internal and external items, injections, thermo-labile
products, cytotoxic drugs, galenical preparations, inflammable and
corrosive liquid and solid pharmaceutical items and biological items shall
be provided.

v) The areas shall have air-conditioning facilities working 24 hours

maintained between 18-25°C.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 39

 vi) Temperature of the storage area and pharmaceutical refrigerators shall
be monitored and documented daily.

vii) Temperature control probe shall be installed with digital display monitor
fixed outside the room. The pharmaceutical refrigerator shall have
temperature record system with alarm.

viii) Back-up / essential power supply with trigger alarm system shall be made
available for pharmaceutical refrigerators and air conditioning facilities.

ix) Cytotoxic spill kit shall be made available within the Ward Supply
Pharmacy area.

x) The corrosive item storage area shall be equipped with water supply for
emergency wash.

xi) The storage of all inflammable items shall be in a dedicated room / area
built from /equipped with fire retardant materials.

f. Storage Area for Bulk Items (intravenous solution)

i) Adequate storage space for intravenous solutions shall be made

available. Heavy duty open racks and heavy duty plastic pallets shall be
made available.

ii) Appropriate space for material handling equipment shall be provided.

g) Dangerous Drugs / Psychotropic Substances Room

i) Dangerous Drugs and Psychotropic Substances shall be stored under

lock and key in accordance with the requirement of relevant Acts and
Regulations and equipped with trigger alarm system.

ii) There shall be a dedicated space for issuing and transit prior to collection.

h) Drug and Poison Information Services Area

i) There shall be a dedicated room, furnished with appropriate furniture

and equipped with telecommunication and networking system in
handling, managing, delivering and disseminating information to
patients and care givers.

ii) Adequate number of personal computers, personal digital assistants

(PDA), printers, and telephone shall be provided.

iii) Source of references such as Micromedex®, Lexicom® of updated version

and other references shall be made available.

iv) A dedicated space for small group discussion shall be made available.

v) Storage space or cabinet for hard copy information and documents shall
be made available.

i) Clinical Pharmacokinetic Services (TDM) Area

i) The service shall be managed by a pharmacist.

40 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 ii) A fully furnished workstation including storage facilities for documents
shall be made available.

iii) Adequate references to ensure accurate and good service quality. shall be
made available.

j) Management and Administrative Area

i) A room shall be provided for the Pharmacist in charged.

ii) A dedicated open office area with furnished workstation and appropriate

INPATIENT PHARMACY
equipment shall be provided.

iii) A fully equipped and furnished meeting and discussion room shall be
provided for Inpatient / Ward Pharmacy activities.

k) Ancillary Area

i) Staff rest room shall be complete with pantry and furniture shall be made
available.

ii) Toilet and changing rooms complete with staff lockers adjacent to staff
rest room shall be provided.

iii) Separate prayer room for male and female complete with ablution
facilities shall be provided.

iv) Extractor fan shall be made available.

l) Cleaner’s / Utility Room

Cleaners / Utility room shall be provided.

m) Disposal Room

This room shall be accessible from outside of the inpatient pharmacy

2.5.3 Satellite Pharmacy

a) Satellite pharmacy shall be made available for hospitals with more than 250
beds. For every 120 beds or 4 wards, one satellite pharmacy shall be provided.
A maximum of 10 satellites shall be considered for hospital with more than
1000 beds.

b) Satellite pharmacy shall also serves as one stop center for discharge
medication.

c) Adequate workspace for dispensing counter, filling and labeling, workstation,

extemporaneous compounding, refrigerator, drug storage, personnel and all
the necessary equipment shall be provided.

d) Adequate space shall be provided for computer hardware (including LCD

monitor, UPS, barcode reader and printers) at the counter and filling station.

e) There shall be adequate parking space for 4 trolleys at one time in the satellite
pharmacy trolley parking bay, in front of the counter. An area of at least 25
square feet (7 square meters) is needed for each trolley.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 41

 f) A minimum of 2 open counters for receiving indents and medication orders
shall be provided.

g) Area for prescriptions filling shall be equipped with benches, racks, stackable
bins and other furniture.

h) Sufficient space is needed to accommodate two medication trolleys at one

time for each filling workbench.

i) Built-in concrete working bench with smooth and acid resistant surface
suitable for pharmaceuticals complete with a stainless steel sink (at least 16
inches deep) shall be provided for extemporaneous preparation.

j) Adequate storage area with air-conditioning facilities running 24 hours daily

shall be made available for drug storage areas. Sufficient built-in open
racks/cabinets shall be provided.

k.) Back-up / essential power supply shall be made available for pharmaceutical
refrigerators and air conditioning facilities.

l) A dedicated open office area with furnished workstation and appropriate

equipment shall be provided.

m) Utility room shall be provided to store cleaning material and equipment.

2.6 SPACE REQUIREMENT

Refer Appendix A2 Space Requirement For Ward Supply Pharmacy and Satellite
Pharmacy.

2.7 EQUIPMENT REQUIREMENT

Refer Appendix C2: Equipment Requirement for Inpatient and Satellite Pharmacy. The
equipment required in each facility is governed by the activities, services, function and
workload.

2.8 MANPOWER REQUIREMENT

Refer Appendix D2: Manpower Requirement for Inpatient and Satellite Pharmacy.
Manpower requirement is base on man-hours or full time equivalent. Therefore the design
and planning of Inpatient Pharmacy shall consider the period and time of activities
performed by Inpatient Pharmacy.

42 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 APPENDIX A2 : SPACE REQUIREMENT FOR WARD SUPPLY PHARMACY AND SATELLITE PHARMACY

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Inpatient Pharmacy Area (square meter)

Hospital Ward Extempora- Storage Area Office Areas Drug and Areas for Personnel
Size (No. Supply/ neous ––––––––––––––––––––––––––––––––––––––––––––––––––– Poison –––––––––––––––––––––––––––––––––––––– Satellite
of Beds) Issuing Preparation Drugs Bulks Pharmacist Office Information Prayer Toilet Rest Room Pharmacy
Area Area Office Space Room Room & Pantry
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
< 250 28 10 28 28 12 (1 U44) 38 14 - 2x8 38 80 x 2
(3 U41 &
1 U32)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
250-500 38 10 48 48 12 (1 U44) 65 14 - 2x8 42 80 x 4
(5 U41 &
1 U32)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
500-700 48 10 56 65 14 (1 U48) 150 14 2 x 14 4x8 48 80 x 6
(2 U44,
7 U41,
1 U36 &
1 U32)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
700-1000 56 10 65 75 14 (1 U48) 186 18 2 x 14 4x8 65 80 x 8
(2 U44,
11 U41,
1 U36 &
1 U32)
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
>1000 65 10 75 94 14(1 U48) 200 20 2 x 20 4x8 70 80 x 10
(2 U44,
> 11 U41,

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA

1 U36 &
2U32)

l 43
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

INPATIENT PHARMACY
APPENDIX B2.1 : EXAMPLE OF DESIGN AND LAYOUT PLAN FOR WARD SUPPLY PHARMACY

44 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 APPENDIX B2.2 : EXAMPLE OF DESIGN AND LAYOUTPLAN FOR SATELLITE PHARMACY

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA

l 45
INPATIENT PHARMACY
 APPENDIX C2 : EQUIPMENT REQUIREMENT FOR INPATIENT PHARMACY

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
WARD SATELLITE
NO. ITEMS SUPPLY
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
1 Bar Code Reader 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
2 Bar Code Labeler 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
3 Bins(Stackable, various sizes) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
4 Book Shelf 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
5 Cabinet Filling 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
6 Cabinet Stainless Steel (Unit Dose) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
7 Cabinet, Dangerous Drugs with audio / alarm system 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
8 Calculator, scientific 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
9 Central Air-Condition, Split Unit 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
10 Chair (Office) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
11 Chair (Adjustable for Dispensing) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
12 Chair (Visitor) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
13 Clock 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
14 Close Circuit TV 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
15 Computer, notebook 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
16 Computer 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
17 Counter, with internet access plug points 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
18 Compactors 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
19 Dixon Angle 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
20 Distiller, water purifier 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
21 Dining Set For 6 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
22 Electric Kettle 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
23 Facsimile machine 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
24 Fire extinguisher 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
25 Freezer capacity 125L 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
26 Hand-held PDA 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
27 Labeler Machine 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
28 Labeler (Hand) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
29 Ladder Aluminum 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
30 Measuring cylinder 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
31 Machine, Photostat 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
32 Microwave 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
33 Mill care Storage Cabinet 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
34 Mirror 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
35 Mortar & Pestle 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

46 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
WARD SATELLITE
NO. ITEMS SUPPLY
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
36 Notice board 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
37 Pneumatic tube 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
38 Printer, Inkjet 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
39 Printer LaserJet A4 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
40 Printer LaserJet Color 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
41 Projector Screen

INPATIENT PHARMACY
3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
42 Projector/LCD, (preferably fixed to ceiling) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
43 Refrigerator, Pharmaceutical 2 / 3 door (Glass) with
anti-frost, alarm 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
44 Refrigerator, Domestic 225 L 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
45 Scale electronic, weighing (0.5kg) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
46 Scanner, computer 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
47 Sealer machine 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
48 Spatula 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
49 Staff locker 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
50 Steps, mobile 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
51 Sofa Set For Personnel Rest Room 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
52 Shoe Rack 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
53 Shredder (Heavy Duty) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
54 Table, Dining For 6 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
55 Table for Meeting Room 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
56 Table/Office Chair 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
57 Toaster 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
58 Trolley, 2-tier stainless steel 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
59 Trolley, Instruments with guard rail (Unit Dose) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
60 Trolley, Issue satellite pharmacy 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
61 Trolley, Medication (Unit Dose) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
62 Trolley, Medication (Emergency) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
63 Trolley (Hand) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
64 Trolley, Multipurpose platform (heavy duty) 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
65 Truck, Pallet (heavy duty ), Store 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
66 Television And DVD Player For Meeting / Discussion /
Seminar room 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
67 Vacuum Cleaner 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
68 Water Dispenser 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
69 White Board (Magnetic) 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 47

 APPENDIX D2 : MANPOWER REQUIREMENT FOR INPATIENT PHARMACY

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Human Resource Number of Staff

Hospital Hospital Hospital Hospital Hospital

(< 250 (250-500 (501-700 (701-1,000 (>1,000
beds) beds) beds) beds) beds)
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist JUSA C - - - - 1
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist U54 - - 2 4 4
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist U52 - 1 4 4 4
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist U48 1 2 4 4 4
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist U44 4 4 8 10 14
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist U41 4 8 12 14 18
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist Assistant U38 - - 1 2 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist Assistant U36 1 2 3 4 5
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist Assistant U32 2 4 4 4 4
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmacist Assistant U29 2 4 4 5 6
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pekerja Rendah Awam R4 1 2 4 6 8
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pekerja Rendah Awam R1 3 5 8 10 12
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Norms: 1 pharmacist to every 4 wards (28 bedded / ward) for medication supply

48 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
3 PRODUCTION PHARMACY
3.1 INTRODUCTION 50
3.2 OBJECTIVE AND SCOPE 50
3.3 POLICIES 50
3.3.1 General Operational Policies 50
3.3.2 General Development & Maintenance Policies 51
3.4 STERILE PREPARATION FACILITIES 52
3.4.1 Policies 52
3.4.2 Design, Layout and Specification 53
3.4.3 Cytotoxic Drug Reconstitution (CDR) 54
a) Facility Requirement 54

PRODUCTION PHARMACY
b) List of Equipment Required 57
3.4.4 TPN/IV Admixture/Eye Drop (Non-CDR) 57
a) Facility Requirement 57
b) List of Equipment Required 59
3.5 NON-STERILE PREPARATION FACILITIES
3.5.1 Policies 59
3.5.2 Design, Layout and Specification 60
3.5.3 Galenical Preparation 61
a) Facility Requirement 61
b) List of Equipment Required 62
3.5.4 Repacking Area 62
a) Facility Requirement 62
b) List of Equipment Required 62
3.6 MANAGEMENT AND QUALITY CONTROL AREA 62
3.6.1 Pharmacist In-Charge’s Room 62
3.6.2 Meeting / Discussion 63
3.6.3 Documentation and Storage of Records 63
3.6.4 Quality Control 63
3.7 STORAGE AND DISTRIBUTION AREA 63
3.8 ANCILLARY AREAS 64

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
LIST OF APPENDIX
3.9.1 Example of Layout Plan for Cytotoxic Drug Reconstitution (CDR) Preparation Facilities 65
3.9.2 Example of Layout Plan for TPN/IV Admixture/Eye Drop (Non-CDR) Preparation Facilities 66
3.9.3 Air Locks For Personnel and Materials in Clean Rooms 67
3.9.4 Examples of Types of Construction Material 68
3.9.5 Clean Room Classification 70
3.9.6 Example of Layout Plan for Non-Sterile Preparation Facilities 71
3.9.7 List of Equipments for Sterile Preparation Facilities 72
3.9.8 List of Equipments for Non-Sterile Preparation Facilities 74
3.9.9 Minimum Manpower Requirement for Production 76
PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 49
3. PRODUCTION PHARMACY

3.1 INTRODUCTION

Preparation of pharmaceutical products in hospitals involves the activities such as

preparation of sterile and non-sterile products in relatively small quantity and normally for
in-house use only. The activities are carried out in a Production Pharmacy Unit under the
management of the Hospital Pharmacy Department.

3.2 OBJECTIVE AND SCOPE

The objective of the production pharmacy service is to produce pharmaceutical products

that are safe, efficacious and of quality. The production facilities only produce
pharmaceutical products that are either not readily available commercially, not cost-
effective to be purchased or not practical to be transported from outside the hospital.

3.3 POLICIES

3.3.1 General Operational Policies

a) Preparation activities shall be kept minimal strictly for pharmaceutical

products mentioned in the objective and scope of this document. Wherever
possible, ready made pharmaceutical products shall be purchased.

b) CDR facility shall be made available in each state hospital and hospitals with
relevant disciplines.

c) Parenteral Nutrition preparation facility shall be made available in hospitals

with ICU, NICU and surgical units.

d) IV Admixture preparation service shall be made available in all hospitals.

e) Preparation of pharmaceutical products shall be carried out in accordance to

the appropriate Good Preparation Practice (GPP) requirements.

f) GPP requirements for products prepared in hospitals shall be in accordance to

Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guide to Good
Practices for Preparation of Medicinal Products in Healthcare Establishments.

g) Products and materials shall be stored in accordance to Malaysian Good

Storage Practice Guidelines (GSP).

h) Pharmacist shall be in charge of the Production Pharmacy Unit.

i) All pharmacy personnel shall be trained continuously and appropriately

according to their job functions. There shall be sufficient personnel for
efficient and effective operations of the preparation facilities.

50 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 j) Personnel working in controlled areas and clean rooms shall be selected with
care, to ensure that they can be relied on to observe the appropriate codes of
practice and not having any diseases or conditions that could compromise the
integrity of the product. Personnel working in clean-room areas shall be
qualified according to approved personnel qualification procedures.

k) Quality control tests of products prepared for multiple doses shall be done in
the attached Quality Control Room, minimum of 100 sq ft. The products shall
be released only by the pharmacist in-charge of the facility or any authorized
person.

l) All preparation activities shall be done according to approved procedures and

recorded in the appropriate batch preparation record. Upon completion of
the preparation process, all finished products shall be labeled and checked
accordingly prior to release. Preparation and quality control records shall be
maintained for a period of two years from the date of preparation.

m) Quality control on all products shall be carried out in-house and/or

outsourced.

PRODUCTION PHARMACY
n) Preparation areas including clean rooms shall be maintained regularly
according to approved, planned preventive maintenance procedures
o) Dispensing bottles for internal and external galenical products shall be
procured clean and ready to be used.

p) Preparation facility shall be inspected for pre-qualification by the Pharmacy

Practice and Development Division, Ministry of Health prior to start operation.
If the facility is found to be satisfactory, an approval letter for use shall be
issued by the Pharmacy Practice and Development Division.

q) All preparation facilities shall be inspected routinely by the Pharmacy Practice

and Development Division, at least every 2 years.

3.3.2 General Development & Maintenance Policies

Pharmacy Practice and Development Division has outlined policies for the
development of preparation facilities for pharmaceutical preparations as follows:

a) All pharmaceutical preparations produced in hospitals shall be carried out in

specifically designed and built facilities suitable for their intended use.

b) The Production Pharmacy Unit shall be located in In-Patient Pharmacy of the

Hospital Pharmacy Department.

c.) Clean rooms shall be located within an air-conditioned area, to minimize

condensation problem.

d) All Production Pharmacy Unit shall have dedicated rooms/areas for:

• personnel change
• material weighing
• product preparation
• product labeling
• quality control activities
PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 51
 • housekeeping
• water treatment system
• waste disposal
• storage and distribution
• documentation
• management and administration
• other ancillaries

e) If space permits, a one-way flow of production processes shall be adhered to.

f) Preparation of labels, dispensing of envelopes and labeling of containers shall

be carried out in the same labeling room within the non-sterile preparation
area.

g) The minimum recommended room size shall be double the space required for
equipment, furniture and other facilities placed therein for performing the
operations.

h) Quality control activities for sterile and non-sterile products shall be carried
out within the same quality control room.

i) Appropriate numbers of electrical plug points shall be made available for each
room whenever required.

j) Dedicated storage area/store for cytotoxic drugs shall be made available.

3.4 STERILE PREPARATION FACILITIES

Preparation of sterile pharmaceutical products in hospitals involves the activities such as

preparation of eye drops, intravenous admixtures, parenteral nutritions and cytotoxic drug
reconstitutions. For the purpose of these guidelines, the sterile preparation facilities are
classified into Cytotoxic Drug Reconstitution (CDR) and Non-Cytotoxic Drug Reconstitution
(Non-CDR).

3.4.1 Policies

a) All sterile pharmaceutical preparations shall be produced in a qualified clean

room facilities designed and built in accordance to Good Preparation Practice
(GPP) requirements.

b) Clean rooms shall be designed and built by experienced clean room

contractors. The proposed layout plan, grades and control parameters shall be
submitted to the Pharmacy Practice and Development Division, Ministry of
Health for approval prior to the development of the facilities.

c.) The calibration of equipment including the monitoring devices used in clean
rooms shall be conducted by an accredited agent.

d) Upon commissioning, clean rooms and their major equipment (laminar

airflow cabinet and cytotoxic drug safety cabinet/isolator) shall be tested by
an independent third party agent for confirmation of compliance to

52 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 standards. The testing agent shall be certified by appropriate certification
bodies such as National Associations of Testing Authorities (NATA - Australia)
or National Environmental and Balancing Bureau (NEBB - USA).

e) Prior to use, clean room facilities have to be inspected and qualified by the
Pharmacy Practice and Development Division, Ministry of Health Malaysia.
Approval letter for use will be issued by the Pharmacy Practice and
Development Division.

f) Clean rooms, unidirectional airflow cabinet and cytotoxic drug safety

cabinet/isolators shall be maintained regularly according to approved
planned preventive maintenance procedures. The maintenance shall include
thorough cleaning and testing by the certified testing contractor. Microbial
monitoring shall be done regularly depending on the usage of the facilities
and outcome of the test results.

g) Qualified clean room facilities shall be inspected routinely by the Pharmacy

Practice and Development Division, Ministry of Health Malaysia at least every
2 years.

PRODUCTION PHARMACY
3.4.2 Design, Layout and Specification

a) This area is for sterile preparation activities that may consist of either Cytotoxic
Drug Reconstitution (CDR) Facility, Non-CDR Facility or both.

b) Premises and utilities for CDR Facility shall be separated from Non-CDR Facility
(for eye drops, IV admixtures and parenteral nutritions).

c) The building design shall take into account the flow of the materials, products
and personnel. The layout of the facility shall be in such a way as to avoid
cross-contamination and mix-ups. One way flow of materials, personnel and
finished products is ideal.

d) A recommended total built-up area of 1,200 sq feet shall be made available for
a complete CDR or Non-CDR facility.

e) Air handling systems for sterile preparation facilities shall be dedicated and
shall be fitted with alarms so that the working personnel are warned of any
failure of the systems. The systems shall be able to maintain 24 hours pressure
differentials without cooling whenever the facilities are not in use.

f) Humidity, temperature, pressurization and air filtration or air cleanliness shall

be controlled in order to protect the products, personnel and the
environment. Appropriate devices for measuring and monitoring the
parameters shall be installed or made available (e.g. pressure gauges, thermo-
hygrometers, particle counter). Ideally, the monitoring and alarm systems for
clean rooms shall be made online.

g) Labeling Room shall be designed and laid out so as to avoid mix-ups.

h) Adequate lighting shall be provided in all clean rooms. Normally, a range of

500 - 600 lux ensures personnel comfort and ability to perform work efficiently

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 53

 and effectively. Lights fixtures shall be flush-mounted in the ceiling and sealed
to prevent air leaks. It is preferable that they can be maintained and serviced
from above. Electrical outlets shall be flushed-mounted, watertight, have no
crevices and shall be cleanable.

i) The choice of construction materials is one of the most important

considerations in the facility design. When choosing the materials for floors,
ceilings and walls, the following specifications for the premises shall be
considered:

i) Ceilings, walls, floors, fixtures, shelves, counters and cabinets shall be

resistant to sanitizing agents and crevices free to avoid dirt accumulation.

ii) Construction materials shall resist chipping, shedding, flaking, oxidizing,

or other deterioration.

iii) Junctions of walls, floor and ceiling shall be curved (coved) to facilitate
cleaning.

iv) There shall not be horizontal fixed pipes or conduits over exposed
components, in-process materials, drug products, and drug product
contact surfaces.

v) All service fittings shall be flushed with surrounding surfaces.

vi) The size of all doors shall be sufficient for the equipment to be brought
into.

vii) Airtight ceilings and walls, close fitting doors and sealed light fittings
shall be in place as these all have an impact on the HVAC system (heating,
ventilation and air-conditioning).

j) CCTV system shall be installed.

3.4.3 Cytotoxic Drug Reconstitution

a) Facility Requirements

i) A totally separate clean room area (premises and utilities) shall be

provided for Cytotoxic Drug Reconstitution (CDR) activities that require
containment for the protection of the environment. Entrance and exit of
the CDR room shall be via a containment airlock or a sink airlock (or
negative sink).

ii) A CDR facility shall have personnel changing rooms (for change and
gowning), a component room, a CDR room and a labeling room.

iii) Design of the facility shall consider and fulfill the requirement of
containment. This can be achieved by having a negative airlock adjacent
to the CDR room. Depending on the layout design, this airlock can also
be suitably located to contain the whole facility.

54 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
iv) Although one-way flow of processes is recommended, the requirement
for containment shall not be compromised.

v) Air handling unit (AHU) and its room shall be dedicated. The air handling
system for CDR room shall not be re-circulated and shall be fitted with an
emergency push button for use during spillage.

vi) Flooring shall be a continuous, non-cracking material that is mechanically

and chemically robust. Preferably, floors shall be overlaid with wide sheet
vinyl flooring with heat-welded seams and coving to the sidewall.
Alternatively, self leveling epoxy resin flooring could be used.

vii) Walls and ceilings shall be free from cracks, built with a smooth, non-
shedding, cleanable finish that is impervious to water, cleaning and
sanitizing solution. Wall paneling (e.g. Polyurethane panel) shall be used
for CDR rooms.

viii) Bare wood, ledges and other unsealed surfaces shall be avoided in clean
rooms. Glass window is required for CDR room and it shall be of flushed
double glazed type.

PRODUCTION PHARMACY
ix) There shall be two parts of personnel change room. The second or final
part of the personnel change room leading into the CDR room shall be of
the same grade of the latter.

x) A sink for hand wash can be fitted in the first or earlier part of the change
room. The CDR room shall not contain any sink or floor drains.

xi) Taps shall be elbow, foot or beam-operated. Surfaces materials, including

bench tops, shall have a minimum of joints and seams and be non-
shedding and easy to clean.

xii) All doors for clean rooms shall be fitted with inter-locking systems so that
only one door can be opened at a time to ensure the pressure cascade is
not compromised. All airlock doors shall be provided with self-closers.

xiii) Doors and windows shall have a hard, smooth, impervious finish and
close tightly and also fit flush with surrounding walls.

xiv) A cytotoxic drug safety cabinet or isolator (CDR cabinet/isolator) shall be

used to ensure maximum personnel protection. The cabinet and isolator
used shall be of Grade A standard for the protection of product.

xv) A CDR Isolator shall be used by hospitals with less than 10 CDR
preparations per day.

xvi) Appropriate measuring devices shall be installed for CDR cabinet or

isolator such as :
• Pressure gauges for monitoring the pressure across the HEPA filters
• Down flow sensor for velocity
• A limit window sash sensor shall be available to ensure negativity
within CDR cabinet

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 55

 xvii) The CDR room shall be of Grade B if a cytotoxic drug safety cabinet is
used. If an isolator (negative isolator) is used, the room shall be of at least
Grade D.

xviii) Since the CDR room shall not have a workbench, equipment installed
(either cabinet or isolator) shall come with its own stands. There shall be
sufficient space underneath the cabinet for allowing cleaning process.

xix) A component room shall be of Grade C or D and shall be entered by

personnel via a personnel change room of a similar grade.

xx) Stainless steel sink with an appropriate depth to avoid splashing, stainless
steel shelves, and work bench shall be fitted in the component room.

xxi) A buffer/staging room or a hatch shall be used for transferring in

materials (e.g. components, cleaning materials and equipment). If a one
way flow facility is not possible, the buffer/staging room or hatch can be
used for transferring materials and products out as well.

xxii) Adequate numbers of plug points shall be made available.

xxiii) Plug points connected to essential power supply shall be made available
for pharmaceutical refrigerators. In case of power failure, Uninterrupted
Power Supply (UPS) shall be provided for Cytotoxic Drugs Reconstitution
(CDR) cabinet/ isolator and HVAC system.

xxiv) For existing facilities, a certified contractor shall be appointed to test the
performance of the facilities on a regular basis.

xxv) Heating, Ventilation and Air-conditioning (HVAC) System

• Due consideration shall be given to the placement of ceiling mounted

HEPA filters to avoid creating of air currents inside the cabinet
underneath. Diffusers shall not be used.

• Pre-filters (primary and secondary) of AHU and HEPA filters shall be

changeable from outside the clean room.

• Temperature not more than 22ºC and humidity (55 ± 5%) need to be
controlled primarily for the stability of products and the comfort of
personnel.

• Equipment installed shall not jeopardise the set room conditions

including temperature, humidity, air pressure, noise level, etc.

• The air pressure shall be made higher in the cleaner grade of clean
rooms. The air return grilles shall be at a low-level to sweep or purge
the rooms.

• Air extracted from areas where cytotoxic drugs are reconstituted shall
not be re-circulated; air outlets shall be designed to avoid possible
environmental contamination from particles and vapors.

56 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 xxvi) Environmental control is a critical factor in determining the successful
operation of the manufacturing facility especially a clean room.
Therefore, the design and construction which relates to a clean room
shall include consideration of the following:

• Building finishes and structure

• Air filtration
• Air change rate or flushing rate
• Location of air terminals and directional airflow
• Room pressure
• Particulate loading (viable and non-viable)
• Temperature (not more than 22ºC
• Relative humidity (55 ± 5%)
• Pressure differentials (10 - 15 Pascal’s)
• Material flow
• Personnel flow

b) List of Equipments Required

Refer to Appendix 3.9.7

PRODUCTION PHARMACY
3.4.4 TPN / IV Admixture / Eye Drop (Non-CDR)

a) Facility Requirements

i) Appropriate clean room facilities shall be provided for Non-Cytotoxic

Drugs Reconstitution (Non-CDR) activities such as the preparation of
parenteral nutrition solutions, intravenous admixtures and eye drops.

ii) The facility shall have personnel changing rooms (for change and
gowning), a component room, a preparation room and a labeling room.

iii) Flooring shall be a continuous, non-cracking material that is mechanically

and chemically robust. Preferably, floors shall be overlaid with wide sheet
vinyl flooring with heat-welded seams and coving to the sidewall.
Alternatively, self leveling epoxy resin flooring could be used.

iv) Walls and ceilings shall be free from cracks, built with a smooth, non-
shedding, cleanable finish that is impervious to water, cleaning and
sanitizing solution. Wall paneling (e.g. Polyurethane panel) shall be used
for the preparation rooms.

v) Bare wood, ledges and other unsealed surfaces shall be avoided in clean
rooms. Glass window is required for the preparation room and it shall be
of flushed double glazed type.

vi) There shall be two parts of personnel change room. The second or final
part of the personnel change room leading into the preparation room
shall be of the same grade as the latter.

vii) A sink for hand wash can be fitted in the first or earlier part of the change
room. The preparation room shall not contain any sink or floor drains.
PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 57
 viii) Taps shall be elbow, foot or beam-operated. Surfaces materials, including
bench tops, shall have minimum joints and seams and be non-shedding
and easy to clean.

ix) All doors for clean rooms shall be fitted with inter-locking system so that
only one door can be opened at a time to ensure the pressure cascade is
not compromised. All airlock doors shall be provided with self-closers.

x) Doors and windows shall have a hard, smooth, impervious finish and
close tightly and also fit flush with surrounding walls.

xi) A positive pressure unidirectional airflow cabinet or isolator shall be used

for Parenteral Nutrition and Eye Drop. For IV Admixture preparations, a
negative pressure unidirectional cabinet or isolator is needed. There shall
be sufficient space underneath the cabinet for allowing cleaning process

xii) The preparation room shall be of Grade B if a unidirectional airflow

cabinet is used. If an isolator (positive isolator) is used, the room shall be
of at least Grade D.

xiii) Since the preparation room shall not have a work bench, equipment
installed (either cabinet or isolator) shall come with its own stands.

xiv) A component room shall be of Grade C or D and shall be entered by

personnel via a personnel change room of a similar grade.

xv) A utility cabinet, stainless steel sink with an appropriate depth to avoid
splashing and work bench shall be fitted in the component room.

xvi) A buffer/staging room or a hatch shall be used for transferring in

materials (e.g. components, cleaning materials and equipment). If a one
way flow of facility is not possible, the buffer/staging room or hatch can
be used for transferring materials and products out as well.

xvii) Adequate numbers of plug points shall be made available.

xviii) Plug points connected to essential power supply shall be made available
for pharmaceutical refrigerators. In case of power failure, Uninterrupted
Power Supply (UPS) shall be provided for the unidirectional airflow
cabinet/ isolator and HVAC system.

xix) For existing facilities, a certified agent shall be appointed to test the
performance of the facilities on a regular basis.

xx) Heating, Ventilation and Air-conditioning (HVAC) System

• Due consideration shall be given to the placement of ceiling mounted

HEPA filters to avoid creating of air currents inside the cabinet
underneath. Diffusers shall not be used.

• Pre-filters (primary and secondary) of AHU and HEPA filters shall be

changeable from outside the clean room.

58 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 • Temperature (not more than 22ºC and humidity (55 ± 5%) need to be
controlled primarily for the stability of products and the comfort of
personnel.

• Equipment installed shall not jeopardise the set room conditions

including temperature, humidity, air pressure, noise level, etc.

• The air pressure shall be made higher in the cleaner grade of clean
rooms. The air return grilles shall be at the low-level to sweep or
purge the rooms.

xxi) Environmental control is a critical factor in determining the successful

operation of the manufacturing facility especially a clean room.
Therefore, the design and construction, which related to a clean room
shall include consideration for:

• Building finishes and structure

• Air filtration
• Air change rate or flushing rate
• Location of air terminals and directional airflow

PRODUCTION PHARMACY
• Room pressure
• Particulate loading (viable and non-viable)
• Temperature (not more than 22ºC
• Relative humidity (55 ± 5%)
• Pressure differentials (10 - 15 Pascals)
• Material flow
• Personnel flow

b) List of Equipment Required

Refer to Appendix 3.9.7

3.5 NON-STERILE PREPARATION FACILITIES

Preparation of non-sterile pharmaceutical products in hospitals involves the activities such

as preparation of galenicals and repacking of supplied medicines.

3.5.1 Policies

a) Computer automation system shall be made available for accuracy of

formulating, compounding and labelling.

b) Preparation of galenicals shall only be carried out if commercial products

are not available.

c) Compounding of extemporaneous preparations which are prepared to be

dispensed immediately to the patients, shall be done in specified preparation
areas in the dispensing facilities.

d) Mixing, filling and labeling of a galenical preparation shall not be done

simultaneously with another preparation within the same preparation area.

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 59

 e) Purified water shall be used for the preparation of galenical preparations to
minimize microbial contamination.

f) Medicines supplied or prepared in bulk shall be repacked centrally into ready-

to-dispense units to facilitate dispensing for outpatient and inpatient (Unit
Dose packs). Therefore, dedicated rooms shall be made available within the
non-sterile preparation area for repacking and filling activities.

g) Pharmacy personnel shall be responsible for planning of repacking activities

depending on the level of stock and usage from various units within the
pharmacy department.

h) The labels of packed medicines shall contain product name (generic and
trade), strength, weight/quantity, expiry date, date of packing, product batch
number and manufacturer’s name.

i) The repacked medicines shall be checked and verified prior to storage.

j) Storage of the repacked medicines shall be done according to specifications

by the manufacturer. Sufficient storage area shall be provided and the
medicines shall be arranged accordingly for easy access and traceability.

k) Utility room shall be provided for storing of housekeeping equipment and

shall be well ventilated to facilitate drying processes of mops and towels.

l) A disposal room shall be situated in such a way that it can be accessible from
both sides. This is to avoid the preparation personnel from going out to throw
the garbage and to prevent garbage collector from entering the preparation
area.

m) Equipments in direct contact with materials used for production of internal

and external preparations shall not be shared. (e.g. tanks, stirrer, mortar and
pestle, jugs)

3.5.2 Design, Layout and Specification

a) The building design shall take into account the flow of the materials, products
and personnel. Personnel, equipment and work-in-process shall not be moved
through areas in which other operations are running.

b) Adequate lighting shall be provided in all preparation areas. Normally, a range

of 500 - 600 lux ensures personnel comfort and ability to perform work
efficiently and effectively. Lights fixtures shall be flush-mounted in the ceiling
and sealed to prevent air leaks. Electrical outlets shall be flushed-mounted,
watertight, have no crevices and shall be cleanable.

c) The choice of construction materials is one of the most important

considerations in the facility design. When choosing the materials for floors,
ceilings and walls, the following specifications for the premises shall be
considered:

i) Ceilings, walls, floors, fixtures, shelves, counters and cabinets shall be

resistant to sanitizing agents and crevices free to avoid dirt accumulation.
60 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 ii) Construction materials shall resist chipping, shedding, flaking, oxidizing,
or other deterioration.

iii) Junctions of walls, floor and ceiling shall be curved (coved) to facilitate
cleaning.

iv) There shall not be horizontal fixed pipes or conduits over exposed
components, in-process materials, drug products, and drug product
contact surfaces.

v) All service fittings shall be flushed with surrounding surfaces.

vi) The size of all doors shall be sufficient for the equipment to be brought
into.

vii) Asbestos shall not be used for constructing the ceilings.

d) Dedicated HVAC system shall be provided for the whole area of non-sterile
preparation facilities.

PRODUCTION PHARMACY
3.5.3 Galenical Preparations

a) Facility Requirement

i) Personnel entering into Galenical Preparation Area shall be through a

personnel change room.

ii) Rooms for external and internal galenical preparations shall be separated
and well ventilated. Equipments used for these preparations also shall be
dedicated.

iii) Since the mixing and packing of galenical preparations are done in the
same room (i.e. galenical preparation room), the activities shall be carried
out product by product to avoid the risk of cross contamination and mix-
up.

iv) Washing room shall be used for washing and drying of bottles and
preparation equipment. This room shall be situated close to the internal
and external preparation rooms to minimize movements of heavy loads.

v) The preparation and washing rooms shall have:

• A built-in concrete working bench with smooth and acid resistant

work surface.

• A deep stainless steel sink with 5 µm filter apparatus for water outlets.

vi) The facilities shall also be used to carry out repacking of liquid / semi solid
(external and internal) medicinal products which are supplied in bulk,
according to the needs.

vii) A holding area for galenical preparations / bulk products to be packed /

repacked shall be provided within the room.
PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 61
 viii) Water treatment plant for supplying treated/purified water (preferably
reverse osmosis) shall be located close to the Galenical Preparation Area.
Depending on the type of treated/purified water system installed, the
accessibility to the plant shall be from outside.

ix) Weighing room shall be equipped with weighing balances suitable for
weighing of large and small quantity of raw materials. These balances
shall be calibrated at least once a year by an accredited agent.

x) Since drains can be a potential source of microbial hazard, an air break

shall be included between drain and sewer to eliminate the possibility of
back-flow. A trap-gully shall be installed to prevent pest intrusion.

b) List of Equipment Required

Refer to Appendix 3.9.8

3.5.4 Repacking Area (Dry)

a) Facility Requirements

i) Personnel entering into repacking area shall be through a personnel

change room

ii) In order to avoid mix-up, repacking of different products shall not be

done in the same room simultaneously

iii) Preparation of labels, dispensing envelopes and labeling of containers

shall be done in the Labeling Room

iv) A holding area for products to be repacked shall be provided within the
room.

b) List of Equipment Required

Refer to Appendix 3.9.8

3.6 MANAGEMENT AND QUALITY CONTROL AREA

This area consists of an administration office for preparation planning, documentation and
quality control activities.Thus, appropriate facilities for an office shall be provided. An open
office space for personnel with computer terminals shall be made available according to
norms and working space for sufficient number of personnel. Within this office area there
shall be rooms for:

3.6.1 Pharmacist In-Charge’s Room

Room shall be provided for Pharmacist in-charge of the Production Pharmacy Unit,
Pharmacist in-charge of non-sterile preparation facilities, Pharmacist in-charge of
CDR facilities and Pharmacist in-charge of TPN facilities. Their rooms shall be
strategically located to allow supervision and administrative works. Each room shall
be equipped with:
62 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 a) Computer and printer including ‘Uninterrupted Power Supply’
b) Table and chairs
c) Telephone
d) Filing cabinets
e) Pneumatic tube terminal (optional, except for Pharmacist in-charged of CDR
facilities)

3.6.2 Meeting / Discussion

This room shall be equipped with chairs, tables, white board and LCD projectors.

3.6.3 Documentation and Storage of Records

Adequate space is required to hold 2 years documents such as batch records,

preparation procedures and distribution records. This room shall be equipped with
metal filing cabinets, telephone, fax, tables, chairs and computer.

3.6.4 Quality Control

a) Basic quality control procedures shall be carried out on finished products in

PRODUCTION PHARMACY
the attached Quality Control Room.This room can be used for sterile and non-
sterile products quality control activities. The room shall have:

i) A built-in concrete working bench with smooth and acid resistant work
surface.

ii) A deep stainless steel sink with 5 µm filter apparatus for water outlet.

b) Quality control tests that cannot be performed in-house shall be outsourced.

(E.g. microbial test)

3.7 STORAGE AND DISTRIBUTION AREA

3.7.1 This section shall have sufficient reception area (receiving and dispatch bays). The
area shall be designed to protect materials and products from the weather and
equipped to allow containers of incoming materials to be cleaned where necessary
before storage.

3.7.2 Sufficient storage area including shelves (or racking system) shall be provided for
storage of products and materials including disposables.

3.7.3 Storage areas shall be designed to ensure good storage conditions e.g. clean, dry
and maintained. If special storage conditions are required (e.g. temperature and
humidity) these shall be provided, checked and monitored regularly using
appropriate devices.

3.7.4 Stores shall be equipped with:

a) Pharmaceutical refrigerator
b) Storage shelves
c) Table/chairs

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 63

 d) Trolley (stainless steel)
e) Computer

3.8 ANCILLARY AREAS

a) Rest and refreshment rooms shall be separated from preparation and control areas.
This room shall be equipped accordingly.

b) Facilities for changing and storing clothes and for washing and toilet purposes shall
be easily accessible and appropriate for the number of users. Toilets shall not
directly communicate with preparation or storage areas.

c) Adequate office space for staff shall be made available.

d) The qiblat direction of Muslim Male and Female prayer rooms with ablution
facilities shall not be facing any nearby toilet.

e) Utility room shall be equipped for storing of housekeeping equipment and shall be
well ventilated to facilitate drying processes of mops and towels.

64 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 APPENDIX 3.9.1 : EXAMPLE OF LAYOUT PLAN FOR CYTOTOXIC DRUG RECONSTITUTION (CDR) PREPARATION FACILITIES

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA

l 65
PRODUCTION PHARMACY
APPENDIX 3.9.2: EXAMPLE OF LAYOUT PLAN FOR TPN / IV ADMIXTURE / EYE DROP (NON-CDR) PREPARATION FACILITIES

66 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
APPENDIX 3.9.3 : AIR LOCKS FOR PERSONEL AND MATERIALS IN CLEAN ROOMS

PRODUCTION PHARMACY

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 67

 APPENDIX 3.9.4 : EXAMPLES OF TYPES OF CONSTRUCTION MATERIAL

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
INTERIOR
SURFACE TYPES OF MATERIALS COMMENTS SUITABLE FOR
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
FLOOR a) Solid concrete - dust accumulating Store areas only
- non resistant to chemical
spills
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
b) Solid concrete with
the following
alternative finishes:

- Vinyl tiles - limited chemical resistance Non-production areas

- requires welded joints in - offices, corridors and
order to damp proof, abrasive laboratories
- for moderately light usage

- Epoxy, - monolithic, non-porous Production areas,

polyurethane topping with non-skid including clean rooms
or heavy duty surface
vinyl sheets - retards bacterial growth,
abrasive

- Cement tiles - economical and easy to repair Offices and pantry

- requires grouting
- joints are difficult to clean
- non-resistant to chemical
spills
- abrasive
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
WALL a) Bricks or block, - Easily crack of improperly Non-sterile
structural wall of processed production area
high density, - generate dust during
smoothly plastered, demolishing for repair or
made water-proof renovation
by painting with
acrylic or high
polymer enamel
polyurethane or
epoxy
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
b) Polyurethane - non shedding Clean rooms
panels or other - generally maintenance free
suitable equivalent - moderately durable
material - difficult to repair in case of
damage by impact
- crevices at joints need to be
sealed e.g. with flexible
silicone rubber material

68 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
INTERIOR
SURFACE TYPES OF MATERIALS COMMENTS SUITABLE FOR
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
CEILING a) Solid concrete - designed for heavy loads Clean rooms,
painted with acrylic - space above ceiling can be processing and filling
or high polymer used for ducts and servicing areas
enamel or activities
Polyurethane panel
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
b) Suspended - requires supporting steel Non-sterile
work production area
- not suitable for heavy
loadings
- shall be sealed to prevent
contamination from the space
above them e.g. with silicone
rubber
- not suitable for sterile
processing rooms which a

PRODUCTION PHARMACY
monolithic surface is required.
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 69

 APPENDIX 3.9.5 : CLEAN ROOM CLASSIFICATION

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
CLEAN AIR Maximum Particle
ROOM CHANGE Count (> 0.5um)
GRADE RATE Activities/Purpose
& Type of (changes State Per meter3
filter per hour)
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
A >120 at rest 3,520 Laminar flow area for
(ISO 5) vertical air flow: manufacturing of sterile
0.3 m/sec products.
HEPA filter horizontal air flow: in operation 3,520 Space where sterile
0.45 m/sec product is exposed.
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
B at rest 3,520 Clean room for sterile
(ISO 6) products.
>40 Background Environment
HEPA filter in operation 352,000 for Grade A
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
C at rest 352,000 Clean room for
(ISO 7) manufacturing of sterile
>25 products.
HEPA filter in operation 3,520,000 (less critical steps)
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
D at rest 3,520,000 Clean room for
(ISO 8) >20 manufacturing of sterile
(WHO) products -
Secondary in operation Not less critical steps.
filter Defined Also being used for
non-sterile manufacturing
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

Note:
Air change rates are the key to cleaning a room effectively shall it get contaminated.
Hence, the higher the air change rate, the better quality the room. High rates shall be selected
where the air quality is continually challenged - e.g. by dusty environment.

70 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
 APPENDIX 3.9.6 : EXAMPLE OF LAYOUT PLAN FOR NON-STERILE PREPARATION FACILITIES

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA

l 71
PRODUCTION PHARMACY
 APPENDIX 3.9.7 : LIST OF EQUIPMENTS FOR STERILE PREPARATION FACILITIES

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
LOCATION

EQUIPMENT CDR NON-CDR

TPN IV ADMIXTURE
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
PREPARATION ROOM
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Cytotoxic Drug Reconstitution Cabinet
(connected to essential power supply) 3 - -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Unidirectional Airflow Cabinet (connected to
essential power supply) - 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel trolley 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel stools with wheels and
adjustable height 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Intercom System 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Roller mixer 3 - -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Power points 3 3 3
√
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
COMPONENT ROOM
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel rack/shelves for keeping of
sterile bags, syringes, needles, filters, etc. 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Phenolic bench top with stainless steel drawers 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel trolley 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel sink 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Utility cabinet 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Intercom system 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Power points 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
PERSONNEL GOWNING ROOM
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Garment cabinet 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Wall mounted six foot long mirror 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Cross over bench 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel sink (elbow / foot operated or
automated) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Cabinet (to hang street clothes) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Electrical hand dryer 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

72 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
LOCATION

EQUIPMENT CDR NON-CDR

TPN IV ADMIXTURE
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
PERSONNEL GOWNING ROOM
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Liquid soap dispenser / hand sanitizer
(foot operated or automated) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Power points 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Cross over bench 3 3 3

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
LABELING ROOM
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pharmaceutical refrigerator (connected to
essential power supply) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel trolley 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

PRODUCTION PHARMACY
Online display for temperature, relative humidity,
air pressure and particle for clean rooms 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Computers and printers 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Intercom system 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Telephone 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Filing cabinets 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Power points 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pneumatic tube terminal Optional Optional Optional
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 73

 APPENDIX 3.9.8 : LIST OF EQUIPMENTS FOR NON-STERILE PREPARATION FACILITIES

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
LOCATION

EQUIPMENT INTERNAL EXTERNAL DRY REPACKING

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
PREPARATION ROOM
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Height adjustable laboratory stool 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Trolley 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Mortar & pestle 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel mixing tank with lid
(minimum 20L) 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel graduated jugs 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel funnels 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Workbench with shelves 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Planetary stirring unit 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Hotplate 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Power points 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Tablet counting machine 3 - 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Unit Dose liquid packing machine - - 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Unit Dose tablet/capsule packing machine - - 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Sealer machine - - 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
PERSONNEL CHANGING ROOM
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel sink (elbow / foot operated or
automated) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Cabinet (to hang street clothes) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Electrical hand dryer 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Liquid soap dispenser / hand sanitizer (foot
operated or automated) 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Power points 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Cross over bench 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

74 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
LOCATION

EQUIPMENT INTERNAL EXTERNAL DRY REPACKING

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
STAGING ROOM
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Electronic balance 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Plug points 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel table top 3 3 -
√
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
LABELING ROOM / AREA
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel trolley 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Computers and printers 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Telephone 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Filing cabinets 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

PRODUCTION PHARMACY
Power points 3 3 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Pneumatic tube terminal Optional Optional Optional
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
UTILITY ROOM (well ventilated)
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Stainless steel cabinet 3 3 3
√
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
WASHING & DRYING AREA
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Deep stainless steel sink 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Drying shelves 3 3 -
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

PHARMACEUTICAL SERVICES DIVISION, MINISTRY OF HEALTH, MALAYSIA l 75

 APPENDIX 3.9.9 : MINIMUM MANPOWER REQUIREMENT FOR PRODUCTION

––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
HUMAN CDR TPN IV NON- TOTAL
RESOURCES ADMIXTURE STERILE
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
U48 1 1
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
U44 1 1 1 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
U41 2 1 1 2 6
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
U32 1 1 1 3
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
U29 2 2 2 2 8
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
N17 1 1
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
PRA R4 1 1 1 3 6
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––

76 l REQUIREMENT FOR THE DEVELOPMENT OF PHARMACY FACILITIES IN HOSPITALS, HEALTH CLINICS AND OTHER HEALTH FACILITIES